Hologic Aptima HPV assay may produce invalid or false negative results
Hologic is recalling one master lot of the Aptima HPV Assay because the product exhibits potential to generate either invalid or false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the assay may return false negative results, and no injuries are stated in the source.
Plain-English summary
Hologic, Inc. is recalling the Aptima HPV Assay, catalogue number 303585. About 306 units were distributed in California, Florida, Iowa, Illinois, Missouri, North Carolina, New Mexico, Puerto Rico and Tennessee. The FDA has classified this recall as Class II.
The recall was initiated due to product exhibiting potential to generate either invalid or false negative results.
Affected product is master lot 929785, containing one refrigerated box (part number 302883, UDI 15420045500051) and one room temperature box (part number 302885, UDI 15420045500068).
Laboratories can identify affected kits by the part number, master lot and UDI numbers above, and may contact Hologic, Inc. for further information.
The recalled product
- Product
- Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
- Manufacturer
- Hologic, Inc.
- Hazard
- false-negative
- invalid-results
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: The Aptima HPV Assay Kit Part Number 303585
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22