Hologic, Inc.

3 recalls on record

Class II2026-03-25

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.

Hologic, Inc.device

Class II2026-02-18

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.

Hologic, Incdevice

Class II2026-01-21

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Fungal contamination of affected lot with Parengyodontium album.

Hologic, Incdevice