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MEDICAL DEVICE RECALLMODERATE
Aptima HPV Assay
Hologic is recalling the Aptima HPV assay (catalog 303585) due to the potential for invalid or false negative results.
What to do
Contact your laboratory supervisor or Hologic technical support for guidance on retesting samples and managing affected results.
Why it was recalled
Due to product exhibiting potential to generate either invalid or false negative results.
How to identify it
UPC 15420045500051 15420045500068
Brand Name: Aptima HPV Assay
Where it was sold
Distributed in US.
Official source
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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification