FDAFDA · Food and drugs·Recall number Z-2067-2026
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Published May 13, 2026 · Recall initiated: April 22, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Contamination to in-vitro diagnostic test may result in false positives.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- BioFire Diagnostics, LLC
- Distributor
- 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.
- Lot
- Lot #s:0883425,0878825/DI: 00815381020192
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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