Reported Mar 25, 2026 · Ongoing
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- Brand NameAptima
- HPV Assay Product NameAptima
- HPV Assay Model/Catalog Number303585
- Product DescriptionAptima
- HPV assay ComponentNo
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published 303585Lot Code: The Aptima HPV Assay Kit , Master — Lot 929785 contains one 302885Refrigerated Box (PN 302883) and one Room Temperature Box ( ). The following are the UDI number for each box: UDI Number for 3028831542004550005115420045500051 UDI Number for 3028851542004550006815420045500068 - Amount recalled
- 306
Where it was sold
Why it was recalled
Due to product exhibiting potential to generate either invalid or false negative results.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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