Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima
Summary
The FDA issued a Class II for Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Numb by Hologic, Inc.. Reason: Due to product exhibiting potential to generate either invalid or false negative results..
Details
Source
Device Recall
External ID
Z-1586-2026
Action Date
2026-03-25
Status
Ongoing
Category
device
Product Description
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Lot/Code Info: 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
Quantity Affected: 306
Reason for Recall
Due to product exhibiting potential to generate either invalid or false negative results.
Distribution
U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-18
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hologic, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hologic, Inc. have FDA actions?
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1586-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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