Biofire Diagnostics, Llc: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Recall Summary BioFire Diagnostics is recalling certain BioFire Joint Infection Panel test kits (model RFIT-ASY-0138, 30-test kits) due to contamination that could cause false positive results. The affected kits were distributed nationwide across the US and in multiple European, Middle Eastern, and other international locations. This is a Class II recall, meaning the contamination could result in incorrect test results that might lead to unnecessary medical intervention.
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a301febc-0182-4b59-a1a3-75d3c0b96432