Please see the attached information regarding a product recall (correction) involving the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel (part number: RFIT-ASY-0116 and RFIT-ASY0104). bioMérieux has identified a potential signal of increased false positive Norovirus results when using the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel. All unexpired product is potentially impacted.

It has been determined the overall risk of false positive Norovirus reported by the BIOFIRE GI Panel may be serious for patients at greatest risk. False positive results are typically associated with unnecessary treatment and reduced likelihood of identifying the true cause of the patient’s disease. The risk is mitigated by a health care provider’s evaluation of other clinical and diagnostic findings including the context of an evaluation of patient clinical history, travel history, suspicion of infection, clinical presentation, and severity of the disease.

Please see the attached for more information about this urgent recall.

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