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FDA-Device2026-03-25Class IIPROCESSING DEFECT

Hologic Aptima HPV Assay recalled for invalid or false negative test results

Hologic
OTHERNationwide distribution

Stop using Hologic Aptima HPV Assay kits

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.

  • 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.
Hazard

Due to product exhibiting potential to generate either invalid or false negative results.

Sold states
U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Affected count
306
Manufactured in
10210 Genetic Center Dr, N/A, San Diego, CA, United States
Products
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1586-2026

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