BioFire Joint Infection (JI) Panel
The BioFire Joint Infection Panel may be contaminated, leading to false positives.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
BioFire Diagnostics, LLC, of Salt Lake City, Utah, is recalling the BioFire Joint Infection (JI) Panel, an in-vitro diagnostic test, because contamination may result in false positives. The recall involves 106 kits, or 3,180 tests, and began on April 22, 2026. The product was distributed in the U.S. states of Texas, North Carolina, Utah, and Maryland, and internationally in countries including France, Italy, Germany, Spain, and the United Kingdom.
The FDA added the recall to its Enforcement Report on May 6, 2026, and it was listed in the weekly enforcement report on May 13, 2026. The recall was classified by the FDA on May 6, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the UDI-DI and lot code listed under your product.
BioFire Joint Infection (JI) Panel REF: Rfit-ASY-0138, 30 test Kit.
- UDI-DI
- 00815381020192
- Lot
- 0883425
- 0878825
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Texas, North Carolina, Utah, Maryland 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.
- Event ID
- 98776
- Recall No.
- Z-2067-2026
- Company
- BioFire Diagnostics, LLCSalt Lake City, Utah
- Hazard
- Contamination
- Quantity recalled
- 106 kits (3,180 test)
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
