Hologic, Inc. recalls 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.
Read the official notice →- Date
- 2026-03-25
- Country
- United States
- Brand
- Hologic
- Product
- Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Hologic recalls
- 2026-05-20
USHologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D,…
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- 2026-05-06
- US
Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software…
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…
FDA · DeviceHologic, IncWorldwide distribution - US Nationwide and the countries of Asia Pacific,…Official notice → - 2026-02-18
- US
Hologic, Inc recalls 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.
- 2026-01-21
- US
Hologic, Inc recalls ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Fungal contamination of affected lot with Parengyodontium album.
- 2025-02-19
- US
Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product…
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
- 2025-02-12
- US
Hologic, Inc. recalls The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The…
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…
FDA · DeviceHologic, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2026-04-01
- US
- US
- 2026-03-25
- US
Datascope Corp. recalls Battery Charging Station; Model: 0998-00-0802;
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in…
FDA · DeviceDatascope Corp.Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN,…Official notice → - US
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The…
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
FDA · DeviceDiagnostica Stago, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Singapore,…Official notice → - US
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
Due to adapter not being properly aligned or locked in place.
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AZ,…Official notice →