Z-1586-2026 Class II Ongoing
FDA device recall Z-1586-2026 was initiated by Hologic, Inc. on February 18, 2026 and is designated Class II. Reason for recall: Due to product exhibiting potential to generate either invalid or false negative results. The recall status is ongoing. Affected quantity: 306.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2026
- Initiation Date
- February 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 306
Product Description
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.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Code Information
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