FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.

On 03/05/19, Urgent Medical Device Recall (Correction) notices were mailed to customers. Customers were advised, that if they used affected devices, positive Campylobacter and Cryptosporidium results should be confirmed by another method prior to reporting the test results. The firm advised customers that the issue was currently under investigation and they would notify customers if additional pertinent information was uncovered. Customers that further distributed product were asked to notify their customers at once of this product recall. As of 02/26/19, the firm temporarily stopped shipment of affected devices. Customers were asked to complete and return the Acknowledgment of Receipt Form. The following contact information was on the safety notice: 1-800-735-6544 and 801-736-6354. On 03/13/19, Urgent Medical Device Recall (Correction) notices were mailed to customers. Customers were advised that this was an expansion/revision of the previous notice) to include newly manufactured GI panel kit lots and to provide revised recommended actions for use of the affected product. Firm resumed shipment of the product with the following limitations: Limitations: - Users may experience combined rates of false positive Campylobacter and Cryptosporidium results ranging from 0 - 9% while using the GI Panel. The majority of product is expected to exhibit rates below 3%. - For specimens that test positive for Campylobacter and/or Cryptosporidium on the GI Panel: Results should be confirmed by retesting using a new GI Panel pouch or by an alternative assay for Campylobacter and/or Cryptosporidium. Only results from confirmatory retesting for Campylobacter and/or Cryptosporidium should be reported for that analyte. - If confirmatory testing is performed with the GI Panel overall specificity is estimated to be (>99%) of both of these analytes, but may also result in a small reduction in sensitivity (by approximately 2-2.5%; from 97.1% to 94.7% for Campylobacter and