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Sign in to claim this brandHologic, Inc.
United States·US-MF-000001646
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 250 , Campus Drive, Marlborough, United States
- Website
- hologic.com
- —
- —
- [email protected]
- Phone
- +1(800)442-9892
- PRRC Contact
- Marissa Richmond
- EUDAMED SRN
- US-MF-000001646
- FDA FEI Number
- 1000120743
- DUNS Number
- 018925968
Catalogue (874)
Page 1 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Brevera Breast Biopsy System | BREVSTXKITM | FDA UDI | Class II | Active |
| ThinPrep | ThinPrep® Non-GYN Filters, 100pk | FDA UDI | Class I | Active |
| Aptima® | KIT, CONTROLS, HCV QUANT, US IVD | FDA UDI | Class II | Active |
| TLiIQ System | TLiIQ System Analyzer | FDA UDI | Class III | Active |
| Progensa | PCA3 CALIBRATORS AND CONTROLS | FDA UDI | Class III | Unknown |
| Unifi Workspace | Unifi Workspace V1.0 | FDA UDI | Class II | Unknown |
| SecurMark for ATEC | SMARK-ATEC-36-12 | FDA UDI | Class II | Active |
| Cervista | HPV HR (96 Reactions) | FDA UDI | Class III | Unknown |
| Progensa | PSA CALIBRATORS AND CONTROLS | FDA UDI | Class III | Unknown |
| Atec | ATEC STX-1 | FDA UDI | Class I | Active |
| Atec | ATEC RTFA | EUDAMEDFDA UDI | Class II | Active |
| Trident Hd Specimen Radiography | TRI-00002 | FDA UDI | Class II | Active |
| Panther Fusion® | DNA GAS PROBE (ASR) | FDA UDI | Class I | Active |
| ThinPrep | APTIMA TUBE PRINTER, THINPREP GENESIS | FDA UDI | Class III | Active |
| Panther Fusion® | DNA VZV PRIMERS (ASR) | FDA UDI | Class I | Active |
| 3Dimensions | 3DM-SYS-INTL2D-MOB | FDA UDI | Class III | Active |
| Panther Fusion® | DNA, IC Probe (ASR) | FDA UDI | Class I | Active |
| Procleix | West Nile Virus 5K | FDA UDI | N/A | Unknown |
| I-View | I-View Software | FDA UDI | Class II | Active |
| Aptima® | KIT, TER, HBV, VL, 100T, US IVD | FDA UDI | Class II | Active |
| Panther Fusion® | COV OC43 PRIMERS (ASR) | FDA UDI | Class I | Active |
| BioZorb | F0221 | FDA UDI | Class II | Active |
| Aptima® | KIT, CONTROLS, HBV, VL, US IVD | FDA UDI | Class II | Active |
| Aptima® | CMV, CALIBRATOR KIT, APTIMA, IVD | FDA UDI | Class II | Active |
| ThinPrep 5000 Processor | TP-5000 Accessory Kit | FDA UDI | Class III | Active |
| Accuprobe® | KIT,ACCUPROBE,M. TUBERCULOSIS | FDA UDI | Class I | Active |
| MammoPad Radiolucent Cushion | MP201-10 | FDA UDI | Class II | Active |
| Discovey C | Discovery C | FDA UDI | Class II | Unknown |
| Atec | MME-00345 | FDA UDI | Class I | Active |
| Selenia® Dimensions® | ASY-04160-HTC | FDA UDI | Class II | Active |
| Discovery SL | Discovery SL | FDA UDI | Class II | Unknown |
| MyoSure Rod Lens Hysteroscope Instrument Tray | 40-903 | FDA UDI | Class II | Active |
| Procleix | Ultrio Plus 5K | FDA UDI | N/A | Unknown |
| BioZorb | F0203 | FDA UDI | Class II | Active |
| Panther Fusion® | LBLD, VZV PLASMID (UNASSAYED CONTROL) | FDA UDI | Class I | Active |
| Affirm Breast Biopsy Guidance System | ASY-03668 | FDA UDI | Class II | Active |
| Aptima® | KIT, BX 2 (RT) M GEN, 100T, AS, IVD | FDA UDI | Class II | Active |
| Selenia FFDM | ASY-06755 | FDA UDI | Class II | Unknown |
| SecurMark | SMARK-EVIVA-2S-13 | FDA UDI | Class II | Active |
| Atec Pearl | ATEC PEARL | FDA UDI | Class II | Active |
| Selenia FFDM | ASY-01427 | FDA UDI | Class II | Unknown |
| Procleix | Ultrio 1K | FDA UDI | N/A | Unknown |
| Sertera Biopsy Device | Sertera-14 | FDA UDI | Class II | Active |
| TruNode Surgical Gamma Probe | 120-807605 | EUDAMEDFDA UDI | Class I | Active |
| Hologic | UNIVERSAL ARM4/RED FRET | FDA UDI | Class I | Unknown |
| SecurMark | SMARK-E13-SS3 | FDA UDI | Class II | Active |
| Aptima® | KIT, BOX 1, REFRIG, AHSV, 100T, IVD | FDA UDI | Class II | Active |
| 4.0-5.0 Cm Ct Lumen Marker Set | B90003 | FDA UDI | Class II | Unknown |
| 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER | B11245 | FDA UDI | Class II | Unknown |
| Aptima | KIT,APTIMA,HIV-1&HCVQL15 TO30C IVD BOX 3 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
- Hologic BV BE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (63)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 8, 2026 | Z-2168-2026 | — | open, classified | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| Apr 8, 2026 | Z-2167-2026 | — | open, classified | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| Mar 23, 2026 | Z-1949-2026 | — | open, classified | 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. |
| Feb 18, 2026 | Z-1586-2026 | — | open, classified | Due to product exhibiting potential to generate either invalid or false negative results. |
| Dec 15, 2025 | Z-1314-2026 | — | open, classified | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
| Dec 12, 2025 | Z-1093-2026 | — | open, classified | Fungal contamination of affected lot with Parengyodontium album. |
| Jan 15, 2025 | Z-1170-2025 | — | open, classified | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. |
| Jan 8, 2025 | Z-1095-2025 | — | open, classified | 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. |
| Dec 13, 2024 | Z-0907-2025 | — | open, classified | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. |
| Nov 8, 2024 | Z-0694-2025 | — | open, classified | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
| Oct 10, 2024 | Z-0328-2025 | — | open, classified | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. |
| Aug 19, 2024 | Z-3248-2024 | — | open, classified | 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 |
| Jun 13, 2024 | Z-2373-2024 | — | open, classified | 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. |
| Mar 13, 2024 | Z-1733-2024 | — | open, classified | 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 |
| Dec 15, 2023 | Z-0782-2024 | — | open, classified | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. |
| Sep 14, 2023 | Z-1371-2024 | — | open, classified | Use of assay along with plasma specimen may result in error code which would invalidate sample. |
| May 2, 2023 | Z-2035-2023 | — | open, classified | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery |
| Jan 16, 2023 | Z-1144-2023 | — | open, classified | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual |
| Oct 10, 2022 | Z-0669-2025 | — | completed | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set |
| Aug 9, 2022 | Z-1858-2022 | — | open, classified | 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. |
| Mar 18, 2022 | Z-0877-2022 | — | open, classified | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. |
| Jan 27, 2022 | Z-0750-2022 | — | open, classified | Failed stability specifications for reagent kits that may result in false negative test results. |
| Feb 26, 2021 | Z-1369-2021 | — | open, classified | There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. |
| Aug 4, 2020 | Z-2990-2020 | — | terminated | 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. |
| Jan 21, 2020 | Z-1343-2020 | — | terminated | 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. |
| Oct 10, 2019 | Z-2163-2020 | — | open, classified | Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment. |
| Dec 6, 2018 | Z-0685-2019 | — | terminated | Calibration issue not possible to visualize contrast uptake in the subtracted mammography images |
| Jan 20, 2018 | Z-0595-2018 | — | terminated | The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator. |
| Nov 29, 2017 | Z-0677-2018 | — | terminated | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX. |
| Nov 29, 2017 | Z-0676-2018 | — | terminated | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX. |
| Sep 15, 2017 | Z-0027-2018 | — | terminated | An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. |
| Jul 7, 2017 | Z-0351-2018 | — | terminated | The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury. |
| Jun 27, 2017 | Z-2864-2017 | — | terminated | A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results. |
| Oct 28, 2016 | Z-0655-2017 | — | terminated | Breach in sterile barrier compromising product sterility |
| Aug 22, 2016 | Z-2869-2016 | — | terminated | Incorrect label on the Sertera Biopsy Kit |
| Aug 2, 2016 | Z-2766-2016 | — | terminated | Tip Breakage at the glue joint between the obturator body and tip |
| Aug 2, 2016 | Z-2765-2016 | — | terminated | Tip Breakage at the glue joint between the obturator body and tip |
| May 31, 2016 | Z-2239-2016 | — | terminated | Cracks ATEC Canister Lids. |
| Mar 31, 2016 | Z-1579-2016 | — | terminated | Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing. |
| Mar 31, 2016 | Z-1580-2016 | — | terminated | Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing. |
| May 13, 2014 | Z-1700-2014 | — | terminated | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury |
| May 13, 2014 | Z-1701-2014 | — | terminated | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury |
| Jan 24, 2014 | Z-1094-2014 | — | terminated | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, |
| Sep 6, 2013 | Z-2301-2013 | — | terminated | Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images |
| Apr 25, 2013 | Z-1327-2013 | — | terminated | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate. |
| Apr 25, 2013 | Z-1326-2013 | — | terminated | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate. |
| Sep 14, 2012 | Z-2453-2012 | — | terminated | Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180 around vertical axis as well as 180 around a horizontal axis. |
| Sep 14, 2012 | Z-2452-2012 | — | terminated | InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180 around vertical axis as well as 180 around a horizontal axis. |
| Feb 28, 2012 | Z-1370-2012 | — | terminated | SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images |
| Jul 21, 2011 | Z-3015-2011 | — | terminated | The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down |
| Aug 11, 2010 | Z-2285-2010 | — | terminated | The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20. |
| Feb 1, 2010 | Z-1160-2010 | — | terminated | The product is labeled as ATEC0909-12 but it actually contains 0909-20. |
| Apr 7, 2009 | Z-1727-2009 | — | terminated | System may not turn off at the end of the x-ray and cause additional x-ray exposure |
| Apr 7, 2009 | Z-1726-2009 | — | terminated | System may not turn off at the end of the x-ray and cause additional x-ray exposure |
| Apr 7, 2009 | Z-1728-2009 | — | terminated | System may not turn off at the end of the x-ray and cause additional x-ray exposure |
| Apr 7, 2009 | Z-1725-2009 | — | terminated | System may not turn off at the end of the x-ray and cause additional x-ray exposure |
| Sep 24, 2008 | Z-0449-2009 | — | terminated | Software error may lead to a high estimate of major fracture probability. |
| Sep 22, 2008 | Z-0275-2009 | — | terminated | The distal tip of the needle may become detached and remain in the patient, requiring surgical removal. |
| Jun 27, 2008 | Z-2185-2008 | — | terminated | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Z-2186-2008 | — | terminated | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Z-2184-2008 | — | terminated | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Z-2188-1991 | — | terminated | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Z-2187-2008 | — | terminated | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |