Brand Name: Aptima HPV Assay Product Name: Aptima HPV recall
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Why was Brand Name: Aptima HPV Assay Product Name: Aptima HPV recalled?
Due to product exhibiting potential to generate either invalid or false negative results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
- Recalling firm
- Hologic, Inc.
- Quantity
- 306
- Distribution
- U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
- Recall date
- March 25, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)