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.
- Affected units
- 306
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
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