Hologic, Inc.
Device Recalls (Class II)
Class II
Z-1586-2026
·
20260325
·
Ongoing
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.
Source: openFDA Enforcement API