Important Safety Alerts

Medical device manufacturer, bioMerieux, has issued a medical device safety alert concerning its MYLA V4.8.0/4.8.1 and MYLA V4.7.0/4.7.1 in conjunction with bidirectional computer interface (BCI) connect to send data to/from laboratory information system (LIS).

The manufacturer has recently discovered a software anomaly that under certain conditions unwanted alterations to results could be applied when using the BCI Connect scripting feature. It was observed that drugs with result ‘S’(sensitive) or ‘IE’ (insufficient evidence) were changed to ‘R’ (resistant) in LIS. According to the manufacturer, the anomaly can happen with MYLA V 4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI Connect under all of the following specific conditions:

• Use of MYLA V4.8.0/4.8.1 or V4.7.0/4.7.1 with BCI Connect,
• Use one of following LIS protocols: FTP, Shared Folder, RS232 (TCP or Serial),
• Use the Copy/Move/Swap feature of the Scripting configuration,
• Use at least one of the following functions: Copy, Move, Swap, Delete, Uppercase, Lowercase, SetValue, Truncate, Prefix, Suffix, RemoveChars, and;
• The target field that is modified is an antibiotic result

The manufacturer is instructing affected users to update to MYLA version 4.8.2 as soon as possible - the software patch was released on 22-APR-2021, and stop using the rules that allows to change the value in field a4 (Final Category) when using MYLA with BCI Connect (MYLA V4.7.0, 4.7.1 and patched version, MYLA V4.8.0, 4.8.1) before the update.

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 12 May 2021