Recall Z-1586-2026 ยท OYB Kit, Rna Detection, Human Papillomavirus
Hologic, Inc.
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
| Date | Mar 19, 2026 (initiated Feb 18, 2026) |
| Status | Open, Classified |
| Reason | Due to product exhibiting potential to generate either invalid or false negative results. |
| Root cause | Under Investigation by firm |
| Action | On 02/18/2026, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter to customers informing them that Hologic has identified that the Aptima HPV Assay kits from ML 929785 exhibit the potential to generate either invalid results for samples and calibrators or false negative results for low analyte samples when reagents are not used on the day of reconstitution. Customers are instructed: 1. Discontinue use of the Aptima HPV Assay kits from ML 929785. 2. Segregate and count the number of affected product on-hand and dispose according t the local guidelines and regulatio |
| Quantity | 306 |
| Distribution | U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.