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Open, Classified

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

FDA Recall Z-1586-2026 · Posted 2026-03-19

Recalling FirmHologic, Inc.
Recall StatusOpen, Classified
Product CodeOYB
Date Initiated2026-02-18
Product Quantity306

Reason for Recall

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

Firm Action

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 [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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