Recalling firm
BioFire Diagnostics, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-13
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.
Firm state
UT
Product quantity
106 kits (3,180 test)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Contamination to in-vitro diagnostic test may result in false positives.
Product description
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Code / lot info
Lot #s:0883425,0878825/DI: 00815381020192
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.