Class II — Hologic, Inc.
| Recalling firm | HOLOGIC, INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to product exhibiting potential to generate either invalid or false negative results. |
| Product | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No |
| Quantity | 306 |
| Distribution | U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. |
| Initiated | 2026-02-18 |
| Classified | 2026-03-19 |
| Recall number | Z-1586-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hologic, Inc. (Z-1586-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98441/
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