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

Medical DevicesSource: FDA (device) · Date: 2026-05-13

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
BioFire Diagnostics, LLC
Product
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Reason / hazard
Contamination to in-vitro diagnostic test may result in false positives.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-04-22
Code info
Lot #s:0883425,0878825/DI: 00815381020192
Product quantity
106 kits (3,180 test)
Voluntary mandated
Voluntary: Firm initiated
City
Salt Lake City
State
UT
Country
United States
Event id
98776
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