An increased number of customer complaints associated with Vibrio/Vibrio Cholerae false positive detections by the BIOFIRE Filmarray Gastrointestinal (GI) Panel have been observed when using Remel Cary-Blair transport medium. The BIOFIRE GI panel and the Cary-Blair transport medium are performing as intended. Per INV-19261, the root cause of the false positive Vibrio/Vibrio Cholerae results detected by the BIOFIRE GI panel is the presence of non-viable organism in the Remel Cary-Blair transport medium. Recall Start Date: July 4, 2024
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