United StatesBioFire Respiratory Panel 2.1, IVD, REF 423742 (30 test kit), UDI 00815381020529, Lot #2649724 (Expanded Lot #1471725) is being recalled; 97 kits (2,910 pouches) were distributed in AZ, FL, GA, ID, NC, NH, NJ, NY, OR, PA, and SC in the United States. The recall was initiated because unintended movement of pouch chemistry may result in an elevated risk of false negative results and risk of control failures.
What's being recalled
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Recalling firm: BioFire Diagnostics, LLC, Salt Lake City, UT, United States.
How to identify it
UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
The hazard
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
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
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
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)