Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, BioFire Diagnostics LLC, has issued a medical device safety alert concerning its BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module [HKMD No.: 200384].
The manufacturer is informing users about a mandatory BIOFIRE FILMARRAY Gastrointestinal (GI) Panel pouch module software update to ensure that all BIOFIRE GI Panel users are using the most up-to-date software version (FLM2-SFW-0040 v2.0.3.1). The update is to correct a rare false positive Cryptosporidium results reported from customers using the BIOFIRE GI Panel. The BIOFIRE GI Panel contains two assays for the detection of Cryptosporidium: Crypt 1 and Crypt 2. A subset of the unconfirmed Cryptosporidium results appear to be caused by a previously unknown non-specific product that is being generated by the Crypt 2 assay. This amplification product is being erroneously interpreted as “positive” by the current software, leading to a Cryptosporidium Detected result.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 May 2023