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 / numberBarcodesProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.