United StatesBioFire Joint Infection (JI) Panel REF RFIT-ASY-0138, 30 test Kit (lot numbers 0883425 and 0878825; DI 00815381020192), 106 kits (3,180 tests) distributed worldwide including US states TX, NC, UT, MD and multiple countries is affected. The product was recalled because contamination in the in‑vitro diagnostic test may result in false positive results.
What's being recalled
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Recalling firm: BioFire Diagnostics, LLC, Salt Lake City, UT, United States.
How to identify it
Lot #s:0883425,0878825/DI: 00815381020192
The hazard
Contamination to in-vitro diagnostic test may result in false positives.
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
Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.
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)