Hologic, Inc
San Diego, CA
This page shows every FDA and USDA recall linked to Hologic, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
15
Total Recalls
2016
First Recall
2025
Most Recent
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit...
Feb 4, 2025
· Device
Open, Classified
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Jan 14, 2025
· Device
Open, Classified
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Dec 20, 2024
· Device
Open, Classified
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent,...
Mar 22, 2024
· Device
Open, Classified
PANTHER FUSION System REF 9121010000
The Panther System is an integrated nucleic acid testing system which f...
Jan 23, 2024
· Device
Open, Classified
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b...
Apr 6, 2022
· Device
Open, Classified
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents...
Jan 27, 2022
· Device
Open, Classified
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consu...
Feb 26, 2021
· Device
Open, Classified
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Aug 4, 2020
· Device
Terminated
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagen...
Oct 10, 2019
· Device
Open, Classified
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600
Product Usage:
The Panther instrument is a fully auto...
Jan 20, 2018
· Device
Terminated
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Sep 15, 2017
· Device
Terminated
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Jun 27, 2017
· Device
Terminated
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Mar 31, 2016
· Device
Terminated
CF InPlex ASR Card; Catalog Number: 95-0501.
Mar 31, 2016
· Device
Terminated