FDA-Device2026-03-25Class II

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

Hologic, Inc.

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

Original summary

Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No Due to product exhibiting potential to generate either invalid or false negative results. 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 Distribution: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. Affected quantity: 306

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