Hologic Aptima HPV Assay recalled for invalid or false negative test results
Hologic's Aptima HPV Assay test kits (Master Lot 929785) may produce invalid results or false negatives, meaning they could fail to detect HPV infection. The affected kits were distributed to healthcare facilities in California, Florida, Iowa, Illinois, Missouri, North Carolina, New Mexico, Puerto Rico, and Tennessee.
From the FDA notice · Read the official notice ↗ · All Hologic recalls
What to do
- If you use this test in a clinical setting, stop using affected kits immediately and contact your supplier or Hologic for replacement or guidance.
- Review any test results from this lot with your healthcare provider to determine if retesting is needed.
- Check your facility's inventory for Master Lot 929785 with UDI numbers 15420045500051 or 15420045500068.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 306
- Illnesses reported
- None reported
- Manufactured in
- 10210 Genetic Center Dr, N/A, San Diego, CA, United States
- Classification
- Class II
- Recall number
- Z-1586-2026
In the FDA's words
- Description
- Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No Due to product exhibiting potential to generate either invalid or false negative results. 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 Distribution: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. Affected quantity: 306
- Hazard
- Due to product exhibiting potential to generate either invalid or false negative results.