Recall Z-1586-2026
Hologic, Inc. · initiated February 18, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Codes / lots: 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
Reason for recall
Due to product exhibiting potential to generate either invalid or false negative results.
FDA-determined cause: Under Investigation by firm
Action taken
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 regulations. 3.Fill out the Customer Response Form using the link https://iqvia-response.my.site.com/mt/fca?cid=hpv-929785 4. Hologic will process and ship the replacement kits For Questions or concerns, contact Hologic Technical Support at +1 888-484-4747 or +1 858-410-8511 during hours 5 am to 5 pm PT or by email at molecularsupport@hologic.com
Details
- Recall number
- Z-1586-2026
- Initiated
- February 18, 2026
- Posted by FDA
- March 19, 2026
- Product code
- OYB – Kit, Rna Detection, Human Papillomavirus
- Quantity
- 306
- Distribution
- U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
- Recalling firm
- Hologic, Inc., San Diego, CA