- Recalling firm
- Hologic, Inc.
- Reason for recall
- Due to product exhibiting potential to generate either invalid or false negative results.
- Affected products (lot / model / serial)
- 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
- Units affected
- 306
- Distribution pattern
- U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
- Firm location
- San Diego, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1586-2026
- Recall initiated
- February 18, 2026
- FDA classification date
- March 19, 2026
- FDA report date
- March 25, 2026
- FDA event ID
- 98441
- Last updated on HTM Vibe
- July 24, 2026