Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV

FDA device recall Z-1586-2026 · posted 2026-03-19 · Open, Classified

Recall details

Recalling firm

Hologic, Inc.

Reason for recall

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

Action taken

On 02/18/2026, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter to customers informing them that Hologic has identified that the Aptima HPV Assay kits from ML 929785 exhibit the potential to generate either invalid results for samples and calibrators or false negative results for low analyte samples when reagents are not used on the day of reconstitution. Customers are instructed: 1. Discontinue use of the Aptima HPV Assay kits from ML 929785. 2. Segregate and count the number of affected product on-hand and dispose according t the local guidelines and regulations. 3.Fill out the Customer Response Form using the link https://iqvia-response.my.site.com/mt/fca?cid=hpv-929785 4. Hologic will process and ship the replacement kits For Questions or concerns, contact Hologic Technical Support at +1 888-484-4747 or +1 858-410-8511 during hours 5 am to 5 pm PT or by email at molecularsupport@hologic.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OYB

Quantity affected

306

Distribution

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

Date initiated

2026-02-18

Date posted

2026-03-19

Location

San Diego, CA