medical MODERATE Updated 2026-03-25

Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay

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Recalled Product

Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Brand Name: Aptima HPV →

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