FDA recall Z-1586-2026

Hologic, Inc. · Class II · device

Product

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

U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.

Key facts

Status
Ongoing
Initiation date
2026-02-18
Report date
2026-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1586-2026