Warning
BioFire Diagnostics Recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2067-2026Medical Device
BioFire Diagnostics Recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138
BioFire Diagnostics, LLC · Class II — Moderate Risk
Product Description
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Reason for Recall
Contamination to in-vitro diagnostic test may result in false positives.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
BioFire Diagnostics, LLC has recalled a medical device that the FDA classified as Class II affecting 106 kits (3,180 test). The recall was initiated on April 22, 2026. Contamination to in-vitro diagnostic test may result in false positives. It was distributed internationally, including the United States. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.