Biofire Diagnostics, Llc: Biofire Joint Infection (ji) Panel Ref: Rfit-asy-0138, 30 Test Kit

Recall Summary BioFire Diagnostics is recalling certain BioFire Joint Infection Panel test kits (model RFIT-ASY-0138, 30 test size) due to contamination that could cause false positive results. The affected kits were distributed nationwide across the US and in several European, Asian, African, and Latin American countries. This is a Class II recall, meaning the contamination could result in incorrect test results but poses a lower level of risk.

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

U.S. Food and Drug Administration

Recall date

2026-04-22

Status

Ongoing

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 U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/23519249-a4b3-4927-b1a9-7bff4c6f5aa3