Hologic, Inc.
Londonderry, NH, US
Hologic, Inc. appears in FDA device records in Londonderry, NH. FDA records list 189 510(k) clearances between and , 380 PMA records and 5 registered establishments. As of , FDA records show 81 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
6 namesFDA records resolved to Hologic, 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.
- Cytyc Corporationrecall
- Cytyc Prenatal Products/Hologic Inc.recall
- Gen-Probe, Inc.510(k), PMA, enforcement report, recall
- Lorad, A Division of Hologicrecall
- Lorad, A Hologic Co.510(k), recall
- Suros Surgical Systems, Inc.510(k), recall
510(k) clearance history
Showing 50 of 189FDA records hold 189 510(k) clearances for Hologic, Inc. between 1985 and 2026. The busiest year on record is 1990, with 18. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 5 |
| 1987 | 8 |
| 1988 | 4 |
| 1989 | 7 |
| 1990 | 18 |
| 1991 | 5 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 6 |
| 2005 | 4 |
| 2006 | 8 |
| 2007 | 5 |
| 2008 | 4 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 8 |
| 2012 | 10 |
| 2013 | 8 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 2 |
| 2017 | 7 |
| 2018 | 6 |
| 2019 | 8 |
| 2020 | 4 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 7 |
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | KNW | Substantially Equivalent | |
| K253634 | CoolSeal Generator® (CSL-200-90) | GEI | Substantially Equivalent | |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | PCH | Substantially Equivalent | |
| K251868 | Panther Fusion GI Bacterial Assay | PCH | Substantially Equivalent | |
| K243341 | Genius AI Detection 2.0 | QDQ | Substantially Equivalent | |
| K243396 | Aptima SARS-CoV-2 Assay | QQX | Substantially Equivalent | |
| K243935 | Aptima CMV Quant Assay | PAB | Substantially Equivalent | |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | PQA | Substantially Equivalent | |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | QOF | Substantially Equivalent | |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | HIG | Substantially Equivalent | |
| K233352 | Aptima HCV Quant Dx Assay | MZP | Substantially Equivalent | |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | QOF | Substantially Equivalent | |
| DEN210035 | “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” | QYV | Unknown | |
| K231329 | Aptima Neisseria gonorrhoeae Assay | LSL | Substantially Equivalent | |
| K230451 | Aptima® Chlamydia trachomatis Assay | MKZ | Substantially Equivalent | |
| K231316 | Aptima Trichomonas vaginalis Assay | OUY | Substantially Equivalent | |
| K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | QDQ | Substantially Equivalent | |
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | QOF | Substantially Equivalent | |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | OCC | Substantially Equivalent | |
| K221449 | Genius AI Detection 2.0 | QDQ | Substantially Equivalent | |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris | QEP | Substantially Equivalent | |
| K201019 | Genius AI Detection | QDQ | Substantially Equivalent | |
| K202294 | Affirm Contrast Biopsy | IZH | Substantially Equivalent | |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | QEP | Substantially Equivalent | |
| K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit | QEP | Substantially Equivalent | |
| K191281 | Omni Hysteroscope, Omni Lok cervical seal | HIH | Substantially Equivalent | |
| K190694 | Unifi Workspace v1.0.0 | LLZ | Substantially Equivalent | |
| K190515 | Aptima Combo 2 Assay (Panther System) | QEP | Substantially Equivalent | |
| K190452 | Aptima BV Assay | PQA | Substantially Equivalent | |
| K190472 | Aptima CV/TV Assay | PQA | Substantially Equivalent | |
| K182052 | Omni Instrument Tray | KCT | Substantially Equivalent | |
| DEN180047 | Aptima Mycoplasma genitalium Assay | QEP | Unknown | |
| K182727 | Trident HD Specimen Radiography System | MWP | Substantially Equivalent | |
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | HIH | Substantially Equivalent | |
| K181974 | MyoSure XL Tissue Removal Device for Fluent | HIH | Substantially Equivalent | |
| K180825 | Fluent Fluid Management System | HIG | Substantially Equivalent | |
| K180681 | Aptima Combo 2 Assay (Panther System) | LSL | Substantially Equivalent | |
| K173901 | MyoSure MANUAL Tissue Removal Device | HIH | Substantially Equivalent | |
| K180233 | Eviva Stereotactic Guided Breast Biopsy System | KNW | Substantially Equivalent | |
| K172629 | Panther Fusion AdV/hMPV/RV Assay | OCC | Substantially Equivalent | |
| K172282 | Panther Fusion Paraflu Assay | OOU | Substantially Equivalent | |
| K163623 | Quantra | LLZ | Substantially Equivalent | |
| K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes | OCC | Substantially Equivalent | |
| K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | HIH | Substantially Equivalent | |
| K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay | OQO | Substantially Equivalent | |
| K163052 | Brevera Biopsy System with Corlumina Imaging Technology | KNW | Substantially Equivalent | |
| K161575 | Affirm Lateral Arm Upright Biopsy Accessory | IZH | Substantially Equivalent | |
| K153486 | Affirm Prone Biopsy System | IZH | Substantially Equivalent | |
| K153223 | ProParaFlu+ Assay | OOU | Substantially Equivalent | |
| K153219 | ProFlu+ Assay | OCC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222780 | 1000120743 | HOLOGIC, INC. | 250 Campus Dr, Marlborough, MA 01752 US | 2026 | and 29 more, listed in full below |
| 3005496266 | 3005496266 | HOLOGIC, INC. | 600 Technology Drive, Newark, DE 19702 US | 2026 | and 5 more, listed in full below |
| 1221855 | 1221855 | Hologic, Inc. | 4 Navigator Rd, LONDONDERRY, NH 03053 US | 2026 | |
| 2024800 | 2024800 | Hologic, Inc. | 10210 Genetic Center Dr, SAN DIEGO, CA 92121 US | 2026 | and 26 more, listed in full below |
| 3006330030 | 3006330030 | Hologic, Inc. | 445 Simarano Drive, Marlborough, MA 01752 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GTZAntisera, All Groups, Streptococcus Spp.
- GROAntisera, Fluorescent, All Types, Hemophilus Spp.
- IDTApparatus, Melting Point, Paraffin
- IYXCamera, Scintillation (Gamma)
- JJHClinical Sample Concentrator
- HFGCoagulator, Laparoscopic, Unipolar (And Accessories)
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- IFBCytocentrifuge
- KGIDensitometer, Bone
- LIODevice, Specimen Collection
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- MCCDna-Probe, Haemophilus Spp.
- MBTDna-Probe, Reagent, Histoplasma Capsulatum
- MCSDna-Probe, Staphylococcus Aureus
- MCTDna-Probe, Strep Pneumoniae
- LQODna-Reagents, Campylobacter Spp.
- LSKDna-Reagents, Chlamydia
- LQHDna-Reagents, Legionella
- LQFDna-Reagents, Mycobacterium Spp.
- LQGDna-Reagents, Mycoplasma Spp.
- LSLDna-Reagents, Neisseria
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- LKVEnzyme Immunoassay, Fetal Fibronectin
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- KETFilters, Cell Collection, Tissue Processing
- KHOFluorometer, For Clinical Use
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- HIHHysteroscope (And Accessories)
- KNWInstrument, Biopsy
- HIGInsufflator, Hysteroscopic
- MAQKit, Dna Detection, Human Papillomavirus
- JXAKit, Screening, Urine
- KNHLaparoscopic Contraceptive Tubal Occlusion Device
- FMINeedle, Hypodermic, Single Lumen
- LEAPreservative, Cytological
- IZDProbe, Uptake, Nuclear
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KPASlide Stainer, Automated
- KEWSlides, Microscope
- HHMSound, Uterine
- KXKSource, Brachytherapy, Radionuclide
- HZJStain, Papanicolau
- JQWStation, Pipetting And Diluting, For Clinical Use
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- IWJSystem, Applicator, Radionuclide, Manual
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JTWSystem, Transport, Aerobic
- JACSystem, X-Ray, Film Marking, Radiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- KPRSystem, X-Ray, Stationary
- KGXTape And Bandage, Adhesive
- ITXTransducer, Ultrasonic, Diagnostic
- LRPTray, Surgical
- GEHUnit, Cryosurgical, Accessories
- MCYWound Dressing Kit
Recall records
Showing 25 of 81| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2168-2026 | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS. | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | Class II | Open, Classified | |
| Z-2167-2026 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D. | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | Class II | Open, Classified | |
| Z-1949-2026 | Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035. | It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual. | Class II | Open, Classified | |
| Z-1586-2026 | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No | Due to product exhibiting potential to generate either invalid or false negative results. | Class II | Open, Classified | |
| Z-1314-2026 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | Class II | Open, Classified | |
| Z-1093-2026 | ThinPrep CytoLyt Solution. Buffered Cell Wash Solution. | Fungal contamination of affected lot with Parengyodontium album. | Class II | Open, Classified | |
| Z-1170-2025 | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. | Class II | Open, Classified | |
| Z-1095-2025 | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release. | Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results. | Class II | Open, Classified | |
| Z-0907-2025 | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. | Class II | Open, Classified | |
| Z-0694-2025 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. | Class II | Open, Classified | |
| Z-0328-2025 | BioZorb Marker. Radiographic soft tissue marker. | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. | Class I | Open, Classified | |
| Z-3248-2024 | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS) | Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis | Class II | Open, Classified | |
| Z-2373-2024 | Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN | Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability. | Class II | Open, Classified | |
| Z-1733-2024 | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device | Class I | Open, Classified | |
| Z-0782-2024 | PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction. | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. | Class II | Open, Classified | |
| Z-1371-2024 | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars. | Use of assay along with plasma specimen may result in error code which would invalidate sample. | Class II | Open, Classified | |
| Z-2035-2023 | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery | Class II | Open, Classified | |
| Z-1144-2023 | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual | Class II | Open, Classified | |
| Z-0669-2025 | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101 | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set | Class II | Completed | |
| Z-1858-2022 | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable. | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date. | Class II | Open, Classified | |
| Z-0877-2022 | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. | Class II | Open, Classified | |
| Z-0750-2022 | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA | Failed stability specifications for reagent kits that may result in false negative test results. | Class II | Open, Classified | |
| Z-1369-2021 | Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing. | There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. | Class II | Open, Classified | |
| Z-2990-2020 | Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 | Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay. | Class II | Terminated | |
| Z-1343-2020 | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636, | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain