BioFire Joint Infection recall (BioFire Diagnostics, LLC)
Medical deviceClass IIOngoing
Summary: BioFire Diagnostics, LLC is recalling BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.. Reason: Contamination to in-vitro diagnostic test may result in false positives.
What is being recalled
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Why
Contamination to in-vitro diagnostic test may result in false positives.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Maryland, North Carolina, Texas, Utah)
How to tell if yours is affected
Lot #s:0883425,0878825/DI: 00815381020192
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2067-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 22, 2026 |
| Reported | May 13, 2026 |
| Company | BioFire Diagnostics, LLC |
| Company location | Salt Lake City, UT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 106 kits (3,180 test) |
More recalls from BioFire Diagnostics, LLC · all medical device recalls · recalls from April 2026