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Recall Canary
Aptima HPV Assay
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MEDICAL DEVICE RECALLMODERATE

Aptima HPV Assay

Hologic is recalling the Aptima HPV Assay due to the potential for the test to generate invalid or false negative results.

What to do

Contact your healthcare provider or laboratory to determine if your recent HPV test results were affected and if retesting is necessary.

Recalled
Listed
Updated
Recall No.
Z-1586-2026
Agency
FDA
Firm
Hologic, Inc.
Recall ID
98441
Status
ONGOING

Why it was recalled

Hologic is recalling the Aptima HPV Assay due to the potential for the test to generate invalid or false negative results. This recall was distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Aptima HPV Assay

UDI-DI
15420045500051, 15420045500068
Model/Catalog number
303585

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification