FDA DeviceClass IINotable

FDA Recall: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product

Date: 2026-03-25
Brand: Hologic, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to product exhibiting potential to generate either invalid or false negative results.

Hazard

Due to product exhibiting potential to generate either invalid or false negative results.

Remedy

306

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