BioFire Diagnostics, LLC: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Hazard

Contamination to in-vitro diagnostic test may result in false positives.

Details from the source

Reason for recall: Contamination to in-vitro diagnostic test may result in false positives. Distribution: 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. Quantity: 106 kits (3,180 test) Lot/code info: Lot #s:0883425,0878825/DI: 00815381020192

UPC codes

00815381020192

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.