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Hologic, 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
LinkedIn: —
Facebook: —
Email: [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 16 of 18

Device	Model / Reference	Registries	Class	Status
Procleix	Ultrio Negative Calibrators	FDA UDI	N/A	Unknown
BioZorb	F0404	FDA UDI	Class II	Active
Panther Fusion Paraflu Assay	K172282	FDA 510(k)	Class II	Active
Contrast Enhanced Digital Mammography	K123873	FDA 510(k)	Class II	Active
Genius AI Detection 2.0	K243341	FDA 510(k)	Class II	Active
Aptima Neisseria gonorrhoeae Assay	K231329	FDA 510(k)	Class II	Active
Genius AI Detection 2.0	K221449	FDA 510(k)	Class II	Active
Hologic Qdr Explorer X-Ray Bone Densitometer, Model Explorer	K033224	FDA 510(k)	Class II	Active
1.10-Year Fracture Risk Questionnaire Option For Qdr X-Ray Bone Densitometer, Model Qdr Option	K080711	FDA 510(k)	Class II	Active
Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)	K121868	FDA 510(k)	Class II	Active
Aptima Combo 2 Assay (Panther System)	K190515	FDA 510(k)	Class II	Active
Panther Fusion GI Expanded Bacterial Assay	K251993	FDA 510(k)	Class II	Active
Qdr-1000 And Qdr-1000/W X-Ray Bone Densitometer	K905753	FDA 510(k)	Class II	Active
Myosure Hysteroscopic Tissue Removal System	K142029	FDA 510(k)	Class II	Active
Qdr-1000 And With X-Ray Bone Densitometer	K905691	FDA 510(k)	Class II	Active
Nhanes Whole Body Dxa Reference Database	K103265	FDA 510(k)	Class II	Active
Hologic Qdr X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery	K023398	FDA 510(k)	Class II	Active
Hologic Qdr Series X-Ray Boe Densitometers	K963363	FDA 510(k)	Class II	Active
Myosure Xl Tissue Removal Device (1 Pack) Myosure Xl Tissue Removal Device (3 Pack)	K122498	FDA 510(k)	Class II	Active
Affirm Breast Biopsy Guidance System	K103512	FDA 510(k)	Class II	Active
Myosure Intrument Tray	K121280	FDA 510(k)	Class II	Active
Trident Specimen Radiography System, Model : Rc Tri-00001	K111508	FDA 510(k)	Class II	Active
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”	DEN210035	FDA 510(k)	Class II	Active
Hologic Dr Imagepro	K032546	FDA 510(k)	Class II	Active
Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)	K131736	FDA 510(k)	Class II	Active
Digital Spot Mammography System	K100692	FDA 510(k)	Class II	Active
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)	K200866	FDA 510(k)	Class II	Active
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices	K152723	FDA 510(k)	Class II	Active
Trident HD Specimen Radiography System	K182727	FDA 510(k)	Class II	Active
Insight - Fd Mini C-Arm Fluoroscopic Imaging System	K120388	FDA 510(k)	Class II	Active
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths	K182006	FDA 510(k)	Class II	Active
Multiview	K132316	FDA 510(k)	Class II	Active
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay	K242465	FDA 510(k)	Class II	Active
Hologic Qdr-1000 X-Ray Bone Densitometer/Modified	K883280	FDA 510(k)	Class II	Active
Lorad Digital Spot Mammography System	K040884	FDA 510(k)	Class II	Active
ProParaFlu+ Assay	K153223	FDA 510(k)	Class II	Active
Invader Mthfr 1298	K100496	FDA 510(k)	Class II	Active
Apex 2.0 Software For Qdr X-Ray Bone Densitometers	K072847	FDA 510(k)	Class II	Active
X-Caliber Model 1000 Bone Mineral Analyzer	K871553	FDA 510(k)	Class II	Active
Quantra	K120472	FDA 510(k)	Class II	Active
Sertera Biopsy Device	K150169	FDA 510(k)	Class II	Active
Eagle Option For The Qdr Bone Densitometer, Models Qdr4500, Qdr2000, Qdr1500, Qdr4000, Qdr1000, Qdr1000w	K992677	FDA 510(k)	Class II	Active
Aptima SARS-CoV-2 Assay	K243396	FDA 510(k)	Class II	Active
Panther Fusion GI Bacterial Assay	K251868	FDA 510(k)	Class II	Active
Hologic Visceral Fat Software	K113356	FDA 510(k)	Class II	Active
Omni Instrument Tray	K182052	FDA 510(k)	Class II	Active
Omni Hysteroscope, Omni Lok cervical seal	K191281	FDA 510(k)	Class II	Active
Aptima® Chlamydia trachomatis Assay	K230451	FDA 510(k)	Class I	Active
Invader Mthfr 677	K100987	FDA 510(k)	Class II	Active
Invader Factor Ii	K100943	FDA 510(k)	Class II	Active

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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.