BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Contamination to in-vitro diagnostic test may result in false positives.
Quick Facts at a Glance
- Recall Date
- April 22, 2026
- Hazard Level
- HIGH
- Brand
- BioFire Diagnostics
- Geographic Scope
- 1 states
Hazard Information
Contamination to in-vitro diagnostic test may result in false positives.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioFire Diagnostics, LLC or your healthcare provider for instructions. Notification method: E-Mail
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Full Description
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.. Reason: Contamination to in-vitro diagnostic test may result in false positives.. Classification: Class II. Quantity: 106 kits (3,180 test). 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.
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