Becton, Dickinson and Company, BD Biosciences
San Diego, CA, US
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES appears in FDA device records in San Diego, CA. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 64 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Becton, Dickinson and Company, BD Biosciences carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Bd Biosciences510(k), recall
- BD Biosciences, Systems & Reagentsenforcement report, recall
- Becton, Dickinson and Company, BD Bio Sciencesenforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for Becton, Dickinson and Company, BD Biosciences between 2000 and 2015. The busiest year on record is 2000, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2004 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) | OYE | Substantially Equivalent | |
| K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 | GKZ | Substantially Equivalent | |
| K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 | GKZ | Substantially Equivalent | |
| K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 | GKZ | Substantially Equivalent | |
| K071141 | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 | GKZ | Substantially Equivalent | |
| K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 | GKZ | Substantially Equivalent | |
| K060375 | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 | GKZ | Substantially Equivalent | |
| K041074 | BD FACSCANTO WITH BD FACSANTO SOFTWARE | GKZ | Substantially Equivalent | |
| K000611 | STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER | GKZ | Substantially Equivalent | |
| K000897 | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE | GKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015292643 | 3015292643 | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 2600 Melksee Street, San Diego, CA 92154 US | 2026 | |
| 3027394506 | 3027394506 | Becton, Dickinson and Company, BD Biosciences | 155 North McCarthy Boulevard, Milpitas, CA 95035 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LJDAssay, B Lymphocyte Marker
- LIZAssay, T Lymphocyte Surface Marker
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System
- PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- GGLControl, White-Cell
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- LYECytokeratins
- OYEFlow Cytometric Reagents And Accessories.
- PPMGeneral Purpose Reagent
- JPKMixture, Hematology Quality Control
- GGKProducts, Red-Cell Lysing Products
- MVUReagents, Specific, Analyte
- JQWStation, Pipetting And Diluting, For Clinical Use
- MZITest, Qualitative, For Hla, Non-Diagnostic
Recall records
Showing 25 of 64| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2238-2025 | BD Trucount Controls, 30 Test - REF: 340335 | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. | Class II | Open, Classified | |
| Z-2237-2025 | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. | Class II | Open, Classified | |
| Z-2079-2025 | REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation. | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples. | Class II | Open, Classified | |
| Z-2078-2025 | REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation. | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples. | Class II | Open, Classified | |
| Z-0749-2025 | FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users. | Class II | Open, Classified | |
| Z-0748-2025 | FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users. | Class II | Open, Classified | |
| Z-0747-2025 | FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users. | Class II | Open, Classified | |
| Z-0746-2025 | Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users. | Class II | Open, Classified | |
| Z-0745-2025 | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. " It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users | Class II | Open, Classified | |
| Z-0009-2025 | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. | Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy. | Class II | Open, Classified | |
| Z-2351-2024 | BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent. | Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions | Class II | Open, Classified | |
| Z-0641-2024 | CD11b APC: ASR, REF: 340936, and CE, REF: 333143 | In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples. | Class II | Open, Classified | |
| Z-0173-2023 | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping. | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. | Class II | Open, Classified | |
| Z-0172-2023 | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader. | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier. | Class II | Open, Classified | |
| Z-0171-2023 | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader. | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier. | Class II | Open, Classified | |
| Z-1215-2022 | BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry. | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | Class II | Open, Classified | |
| Z-1214-2022 | BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry. | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | Class II | Open, Classified | |
| Z-2333-2021 | BD" Mouse IgG2a Isotype Control APC X39 ASR | Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody. | Class II | Terminated | |
| Z-0562-2021 | BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry. | Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. | Class II | Terminated | |
| Z-1971-2020 | Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis. | False positive reaction on the reagent. | Class II | Terminated | |
| Z-0074-2020 | BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion. | Class II | Terminated | |
| Z-0073-2020 | BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion. | Class II | Terminated | |
| Z-0072-2020 | BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion. | Class II | Terminated | |
| Z-0071-2020 | BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion. | Class II | Terminated | |
| Z-0070-2020 | BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion. | Class II | Terminated |
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