FDAHealthApril 22, 2026

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

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 22, 2026

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.

What's affected?

Product: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Brand: BioFire Diagnostics, LLC
Lot code: 0883425

Additional details

Lot #s:0883425,0878825/DI: 00815381020192

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 106 kits (3,180 test).

View original FDA notice →

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