Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product
- Recall date
- 2026-03-25
- Brand
- Hologic, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to product exhibiting potential to generate either invalid or false negative results.
Recommended action
What to do
306
Product description
Due to product exhibiting potential to generate either invalid or false negative results.