Class IIReported 2026-03-25

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

Recalled by Hologic, Inc.

Reason for Recall

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

Recall Number

Z-1586-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-02-18

Reported

2026-03-25

Distribution

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

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.