Facility

Hologic, Inc.

41 recall(s) on record — most severe on record: Class I.

Key facts

41recalls · worst Class I

5inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2024800
Establishment type	Manufacture Medical Device
Location	10210 Genetic Center Dr SAN DIEGO, CA, US 92121
Registration status	Active · expires 2026
Parent company	HOLOGIC, INC. (owner-operator 9007676)
Brand names	Panther Fusion Paraflu Assay; Panther Fusion Paraflu Assay Controls; Panther Fusion Paraflu Assay Cartridges 96 Tests; Panther Fusion System

Activity by year

Recalls (41)
Inspections (5)

Devices registered here (2)

Parainfluenza Multiplex Nucleic Acid Assay
Product code OOU (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3980
Real Time Nucleic Acid Amplification System
Product code OOI (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.2570

Recalls & enforcement

20263 records

Class IIOngoing2026-04-08
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Class IIOngoing2026-03-23
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 calibratio…
Class IIOngoing2026-02-18
Due to product exhibiting potential to generate either invalid or false negative results.

20254 records

Class IIOngoing2025-12-15
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Class IIOngoing2025-12-12
Fungal contamination of affected lot with Parengyodontium album.
Class IIOngoing2025-01-15
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 IIOngoing2025-01-08
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…

20246 records

Class IIOngoing2024-12-13
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 IIOngoing2024-11-08
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Class IOngoing2024-10-10
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Class IIOngoing2024-08-19
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 b…
Class IIOngoing2024-06-13
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 acc…
Class IOngoing2024-03-13
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…

20234 records

Class IIOngoing2023-12-15
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Class IIOngoing2023-09-14
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Class IIOngoing2023-05-02
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Class IIOngoing2023-01-16
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

20224 records

Class IICompleted2022-10-10
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Class IIOngoing2022-08-09
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 t…
Class IIOngoing2022-03-18
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 IIOngoing2022-01-27
Failed stability specifications for reagent kits that may result in false negative test results.

20211 record

Class IIOngoing2021-02-26
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.

20202 records

Class IITerminated2020-08-04
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 IITerminated2020-01-21
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.

20191 record

Class IIOngoing2019-10-10
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 i…

20182 records

Class IITerminated2018-12-06
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Class IITerminated2018-01-20
The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.

20174 records

Class IITerminated2017-11-29
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.
Class IITerminated2017-09-15
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Class IITerminated2017-07-07
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-appro…
Class IITerminated2017-06-27
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.

20165 records

Class IITerminated2016-10-28
Breach in sterile barrier compromising product sterility
Class IITerminated2016-08-22
Incorrect label on the Sertera Biopsy Kit
Class IITerminated2016-08-02
Tip Breakage at the glue joint between the obturator body and tip
Class IITerminated2016-05-31
Cracks ATEC Canister Lids.
Class IITerminated2016-03-31
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.

20142 records

Class IITerminated2014-05-13
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
Class IITerminated2014-01-24
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,

20132 records

Class IITerminated2013-09-06
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Class IITerminated2013-04-25
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.

20121 record

Class IITerminated2012-09-14
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…

FDA inspections (5)

NAI2024-08-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
OAI2022-10-14
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-12-10
No Action Indicated · Project Evaluation: Devices
NAI2016-12-07
No Action Indicated · Bioresearch Monitoring
NAI2016-06-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Hologic, Inc. (FEI 2024800) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2024800-hologic-inc/

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