United StatesThe Aptima HPV Assay (Brand Name: Aptima HPV Assay, Catalog/Model number 303585; Master Lot 929785) containing one Refrigerated Box (PN 302883, UDI 15420045500051) and one Room Temperature Box (PN 302885, UDI 15420045500068) is being recalled. The recall was initiated because the product has the potential to generate invalid or false negative results; 306 units were distributed in the U.S. to CA, FL, IA, IL, MO, NC, NM, PR, and TN.
What's being recalled
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Recalling firm: Hologic, Inc., San Diego, CA, United States.
How to identify it
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
The hazard
Due to product exhibiting potential to generate either invalid or false negative results.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada