Device product

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

Z-2067-2026

April 22, 2026

Class II

Product summary

Firm: BioFire Diagnostics, LLC
Event: Event 98776
Status: Ongoing
Classification: Class II
Quantity: 106 kits (3,180 test)
Official record key: device-enforcement:Z-2067-2026

Official wording

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

Code information: Lot #s:0883425,0878825/DI: 00815381020192

Distribution pattern: 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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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