Recall Z-1586-2026— Hologic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc., initiated 2026-02-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No. Reason: Due to product exhibiting potential to generate either invalid or false negative results..
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-18
- Firm location
- San Diego, CA, United States
Product description
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Reason for recall
Due to product exhibiting potential to generate either invalid or false negative results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.