Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay
- Recalling company
- Hologic, Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 18, 2026
- Reported
- Mar 25, 2026
- Distribution
- U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
- Status
- Ongoing
- Quantity
- 306
- Lot / codes
- Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box: UDI Number for PN 302883: 15420045500051 UDI Number for PN 302885: 15420045500068
- Company location
- San Diego, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1586-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1586-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.