Important Safety Alerts

Medical device manufacturer, bioMérieux, issued a medical device safety alert concerning the following devices:

Following one customer complaint, the manufacturer confirmed that a MYLA software anomaly can result in a bottle maximum test time (MTT) being reset to the default MTT. The bottle may then be unloaded before the desired incubation time resulting a false negative result.

According to the manufacturer, for this anomaly to occur. The following conditions must be met:

• Using MYLA (V4.7, V4.7.1, V4.8, V4.8.1 or V4.8.2) in conjunction with BCI Connect
• Managing Blood Culture analyses on BACT/ALERT VIRTUO connected to MYLA
• Blood Culture workflow is based on 2 or more bottles with the same specimen (same specimen/laboratory id)
• Using the LIS capability to send Blood Culture requests containing the incubation expected duration (MTT)
• Sending other requests than Blood Culture (Offline SU, ID,) on the same specimen than the one used for BC

If one or more conditions are not met, the manufacturer determined that user's laboratory is not at risk for this anomaly. However, if all conditions are met, users are advised to contact manufacturer. For tests previously performed using MYLA and VIRTUO, users are advised to identify any possible false negative result that may have occurred, to analyse the related risks and to determine appropriate actions.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary action.

Posted on 8 Sept 2021