FDA recall, , Moderate risk
Aptima HPV Assay
The Aptima HPV Assay can generate invalid or false negative results.
Summary by Recall Canary from the FDA notice
What happened
Hologic, Inc., of San Diego, California, recalled the Aptima HPV Assay because the product may generate invalid or false negative results. The recall began February 18, 2026, and was added to the FDA's Enforcement Report on March 19, 2026. The product was distributed in California, Florida, Iowa, Illinois, Missouri, North Carolina, New Mexico, and Tennessee.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
Aptima HPV Assay
- Model number
- 303585
- Lot code
- 929785
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of California, Florida. Iowa, Illinois, Missouri, North Carolina, New Mexico, PR, and Tennessee.
- Company
- Hologic, Inc.San Diego, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98441
- Recall number
- Z-1586-2026
All recalls from Hologic, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
