Brand
Hologic, Inc
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Hologic, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-25FDA-DeviceClass IIBrand 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.
- 2026-02-18FDA-DeviceClass IIBrevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
- 2026-01-21FDA-DeviceClass IIThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Fungal contamination of affected lot with Parengyodontium album.
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