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

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

Code information: 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 pattern: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.