Z-1586-2026Class II

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

Name: Z-1586-2026 Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description...
Creator: Hologic, Inc.
Published: 2026-02-18
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2026-02-18 / Open, Classified

FDA source

Hologic, Inc. began a recall of Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No on 2026-02-18. FDA classified it as Class II and gives the reason as "Due to product exhibiting potential to generate either invalid or false negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1586-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-18
Posted: 2026-03-19
Recalling firm: Hologic, Inc.
Product: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Product code: OYB Kit, Rna Detection, Human Papillomavirus
Reason for recall: Due to product exhibiting potential to generate either invalid or false negative results.
FDA root cause: Under Investigation by 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]
Quantity in commerce: 306
Distribution: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1586-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1586-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-19

Product code OYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)