Aptima recallZ-1586-2026 · Hologic, Inc. · initiated Feb 18, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to product exhibiting potential to generate either invalid or false negative results.
FDA root cause category: Under Investigation by firm
What the company is doing
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]
Recall details
- Recall number
- Z-1586-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 18, 2026
- Posted by the FDA
- Mar 19, 2026
- Recalling firm
- Hologic, Inc.
- Quantity
- 306
- Product code
- OYB
- FDA submissions
- P100042
- Distribution
- U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Product description
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Aptima® KIT, HPV, APTIMA, 250 TEST, REFRIG, IVDHologic, Inc. · Kit, rna detection, human papillomavirus1 recall32 reports
- Aptima® KIT,HPV,APTIMA,250 TEST,ROOM TEMP, IVDHologic, Inc. · Kit, rna detection, human papillomavirus1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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