Medical device manufacturer, BioFire Diagnostics, LLC, has issued a medical device safety alert concerning its BioFire FilmArray Gastrointestinal (GI) Panel [Part Number: RFIT-ASY-0104 & RFIT-ASY-0116].
The manufacturer has identified elevated rates of false positive results for Campylobacter and Cryptosporidium while using the BioFire GI Panel. Only the BioFire GI Panel kits with expiration dates ranging from 23 October 2019 to 20 February 2020 are affected.
According to the manufacturer, if using the affected products, positive results for Campylobacter and Cryptosporidium should be confirmed by another method prior to reporting the test results.
The manufacturer will continue efforts to monitor the issue in the field and will notify users if additional pertinent information is uncovered, as the issue is currently still under investigation. The manufacturer has temporarily stopped shipments of the affected products.
The users are advised to immediately examine their inventory for the product identified in this recall. If they identify any affected lots, they may choose to continue using the affected product, however, positive results for Campylobacter and Cryptosporidium should be confirmed by another method prior to reporting the test results.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 March 2019