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

Hazard

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

Details from the source

Reason for recall: Due to product exhibiting potential to generate either invalid or false negative results. Distribution: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. Quantity: 306 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

UPC codes

15420045500051, 15420045500068

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.