Bio-Rad Laboratories Inc.
Irvine, CA, US
BIO-RAD LABORATORIES, INC. appears in FDA device records in Irvine, CA. FDA records list 128 510(k) clearances between and , 31 PMA records and 6 registered establishments. As of , FDA records show 93 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Bio-Rad Laboratories Inc. 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.
- Bio-Rad Laboratories, Inc., Hercules, CArecall
- Bio-Rad Labroatories Inc.recall
510(k) clearance history
Showing 50 of 128FDA records hold 128 510(k) clearances for Bio-Rad Laboratories Inc. between 1991 and 2019. The busiest year on record is 1993, with 12. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 12 |
| 1994 | 8 |
| 1995 | 11 |
| 1996 | 6 |
| 1997 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 11 |
| 2005 | 4 |
| 2006 | 4 |
| 2007 | 7 |
| 2008 | 2 |
| 2009 | 7 |
| 2010 | 5 |
| 2011 | 2 |
| 2012 | 11 |
| 2013 | 8 |
| 2014 | 6 |
| 2015 | 5 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K183446 | BioPlex 2200 Lyme Total | LSR | Substantially Equivalent | |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | OYX | Substantially Equivalent | |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | MRG | Substantially Equivalent | |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | GKA | Substantially Equivalent | |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | PUQ | Substantially Equivalent | |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | LIP | Substantially Equivalent | |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | JJY | Substantially Equivalent | |
| K161687 | D-10 Hemoglobin A1c Program | PDJ | Substantially Equivalent | |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak | PMN | Substantially Equivalent | |
| DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak | PMN | Unknown | |
| K150300 | Liquichek Cardiac Markers Plus Control LT | JJY | Substantially Equivalent | |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | PDJ | Substantially Equivalent | |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | PDJ | Substantially Equivalent | |
| K143379 | Liquichek Maternal Serum II Control | JJY | Substantially Equivalent | |
| K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | MRG | Substantially Equivalent | |
| K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | LCP | Substantially Equivalent | |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | JJY | Substantially Equivalent | |
| K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | JJY | Substantially Equivalent | |
| K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | JJY | Substantially Equivalent | |
| K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO | JJY | Substantially Equivalent | |
| K133960 | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL | JJY | Substantially Equivalent | |
| K132227 | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY | JJY | Substantially Equivalent | |
| K130528 | BIOPLEX 2200 APLS IGM | MID | Substantially Equivalent | |
| K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | MVM | Substantially Equivalent | |
| K130963 | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK | JJY | Substantially Equivalent | |
| K130761 | LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK | JJY | Substantially Equivalent | |
| K130162 | LIQUID ASSAYED MULTIQUAL PREMIUM | JJY | Substantially Equivalent | |
| K123775 | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK | JJY | Substantially Equivalent | |
| K123798 | LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | JJX | Substantially Equivalent | |
| K123663 | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | JJY | Substantially Equivalent | |
| K123198 | LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA | JJY | Substantially Equivalent | |
| K123021 | BIOPLEX 2200 EBV IGM KIT | LJN | Substantially Equivalent | |
| K122838 | LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK | JJY | Substantially Equivalent | |
| K113610 | ANA-SCREEN WITH MDSS | LKJ | Substantially Equivalent | |
| K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | MXJ | Substantially Equivalent | |
| K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | DIF | Substantially Equivalent | |
| K103834 | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS | MID | Substantially Equivalent | |
| K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | DIF | Substantially Equivalent | |
| K120572 | BIOPLEX 2200 TORC IGG | OMI | Substantially Equivalent | |
| K120439 | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG | LIP | Substantially Equivalent | |
| K112810 | MULTI-ANALYTE DETECTION SYSTEMS | NHX | Substantially Equivalent | |
| K111072 | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL | OPL | Substantially Equivalent | |
| K092587 | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM | LFX | Substantially Equivalent | |
| K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | NHX | Substantially Equivalent | |
| K091303 | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV | JPK | Substantially Equivalent | |
| K091616 | BIOPLEX 2200 MMRV IGG | OPL | Substantially Equivalent | |
| K093577 | LIQUICHEK OPIATE CONTROL | DIF | Substantially Equivalent | |
| K092355 | MONOLISA ANTI-HAV EIA | LOL | Substantially Equivalent | |
| K092353 | MONOLISA ANTI-HAV IGM EIA | LOL | Substantially Equivalent | |
| K090699 | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 | LCP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007886270 | 3008272466 | BIO-RAD LABORATORIES, INC. | 8415 216th St Se, Woodinville, WA 98072 US | 2026 | |
| 3032705 | 3002701146 | BIO-RAD LABORATORIES, INC. | 14620 NE North Woodinville Way, Woodinville, WA 98072 US | 2026 | and 29 more, listed in full below |
| 2016706 | 2016706 | Bio-Rad Laboratories Inc. | 9500 Jeronimo Rd, IRVINE, CA 92618 US | 2026 | and 8 more, listed in full below |
| 3010127294 | 3010127294 | Bio-Rad Laboratories Inc. | 9 Holland, Irvine, CA 92618 US | 2026 | and 9 more, listed in full below |
| 2915274 | 2915274 | Bio-Rad Laboratories, Inc. | 4000 Alfred Nobel Drive, Hercules, CA 94547 US | 2026 | and 63 more, listed in full below |
| 3003756338 | 3003756338 | Bio-Rad Laboratories, Inc. | 2500 Atlas Rd, Richmond, CA 94804 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GKAAbnormal Hemoglobin Quantitation
- CGNAcid, Folic, Radioimmunoassay
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GMQAntigens, Nontreponemal, All
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- JQPCalculator/Data Processing Module, For Clinical Use
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- CHQChromatographic/Fluorometric Method, Catecholamines
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DAKComplement C1q, Antigen, Antiserum, Control
- JCNControl, Cell Counter, Normal And Abnormal
- GGMControl, Hemoglobin
- JCMControl, Hemoglobin, Abnormal
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- DIFDrug Mixture Control Materials
- JJTEnzyme Controls (Assayed And Unassayed)
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- JXNEnzyme Immunoassay, Propoxyphene
- JFTFluorometric, Cortisol
- DIEHeavy Metals Control Materials
- JPDHemoglobin A2 Quantitation
- DGCIge, Antigen, Antiserum, Control
- KSFKit, Quality Control For Blood Banking Reagents
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- GGNPlasma, Coagulation Control
- CDDRadioassay, Vitamin B12
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- CGRRadioimmunoassay, Cortisol
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JQWStation, Pipetting And Diluting, For Clinical Use
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- DJCThin Layer Chromatography, Methamphetamine
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- JJWUrinalysis Controls (Assayed And Unassayed)
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
Showing 25 of 93| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2515-2025 | Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens. | Due to a risk of false positive results that could lead to unnecessary medical treatment. | Class II | Open, Classified | |
| Z-1358-2024 | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. | Class II | Open, Classified | |
| Z-1572-2023 | BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack | APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results. | Class II | Open, Classified | |
| Z-1378-2023 | BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack. | Class II | Open, Classified | |
| Z-1377-2023 | BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives. | Class II | Open, Classified | |
| Z-0342-2023 | CMV IgM EIA, in vitro diagnostic. | Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). | Class II | Open, Classified | |
| Z-1096-2022 | BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack | Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack. | Class II | Open, Classified | |
| Z-1208-2022 | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CDROM parameters for the intended use. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall. | Class II | Open, Classified | |
| Z-0807-2022 | BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL | Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications | Class II | Open, Classified | |
| Z-0806-2022 | BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack | Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications | Class II | Open, Classified | |
| Z-0236-2022 | BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack. | Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure. | Class II | Open, Classified | |
| Z-0235-2022 | BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma | Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure. | Class II | Open, Classified | |
| Z-2982-2020 | BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. | The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650. | Class II | Open, Classified | |
| Z-0082-2022 | BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101 | A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs. | Class II | Terminated | |
| Z-1906-2019 | EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A. | User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS). | Class II | Open, Classified | |
| Z-1743-2019 | MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. | Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. | Class II | Terminated | |
| Z-1742-2019 | MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. | Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. | Class II | Terminated | |
| Z-2541-2018 | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states. | The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system. | Class II | Terminated | |
| Z-0807-2016 | EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays. | The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter. | Class II | Terminated | |
| Z-0695-2016 | D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis. | On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration. | Class II | Terminated | |
| Z-1840-2015 | The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error. | The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error. | Class III | Terminated | |
| Z-1537-2014 | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin. | There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used. | Class II | Terminated | |
| Z-1299-2014 | D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis. | On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample. | Class II | Terminated | |
| Z-0965-2014 | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography. | D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System. | Class III | Terminated | |
| Z-0032-2014 | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. | The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0. | Class III | Terminated |
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