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Hologic, Inc.: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component

Medical DevicesSource: FDA (device) · Date: 2026-03-25

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Hologic, Inc.
Product
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Reason / hazard
Due to product exhibiting potential to generate either invalid or false negative results.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Recall initiated
2026-02-18
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
Product quantity
306
Voluntary mandated
Voluntary: Firm initiated
City
San Diego
State
CA
Country
United States
Event id
98441
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