Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number:... recall (Hologic, Inc.)
Medical deviceClass IIOngoing
Summary: Hologic, Inc. is recalling 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.
What is being recalled
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Why
Due to product exhibiting potential to generate either invalid or false negative results.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. (states named: California, Florida, Iowa, Illinois, Missouri, North Carolina, New Mexico, Puerto Rico, Tennessee)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1586-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 18, 2026 |
| Reported | March 25, 2026 |
| Company | Hologic, Inc. |
| Company location | San Diego, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 306 |
More recalls from Hologic, Inc. · all medical device recalls · recalls from February 2026