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U.S. Department of Health and Human Services

Class 2 Device Recall Aptima HPV Assay

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 Class 2 Device Recall Aptima HPV Assaysee related information
Date Initiated by FirmFebruary 18, 2026
Date PostedMarch 19, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1586-2026
Recall Event ID 98441
PMA NumberP100042 
Product Classification Kit, rna detection, human papillomavirus - Product Code OYB
ProductBrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Code Information 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
FEI Number 2024800
Recalling Firm/
Manufacturer		 Hologic, Inc.
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information ContactMichael Watts
1-858-4108514 Ext. 128
Manufacturer Reason
for Recall		Due to product exhibiting potential to generate either invalid or false negative results.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce306
DistributionU.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OYB
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