Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay… — Class II medical device recall Z-1586-2026
Ongoing recall by Hologic, Inc., reported 2026-03-25, distributed nationwide. Due to product exhibiting potential to generate either invalid or false negative results.
| Recall number | Z-1586-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., San Diego, CA, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-03-19 |
| Reported by FDA | 2026-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 306 |
| UPC / GTIN / UDI-DI | 15420045500051, 15420045500068 |
| Lot numbers | 929785 |
| Model numbers | 303585 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1586-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.