MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

Under certain conditions, there is a risk for a false negative result.

A customer letter was issued to impacted subsidiaries and distributors on 09/08/2021. The letter includes instructions that the customer verify that they operate under the specific conditions required for the anomaly to occur: You are using MYLA (V4.7, V4.7.1, V4.8, V4.8.1 or V4.8.2) in conjunction with BCI Connect AND You are managing Blood Culture analyses on BACT/ALERT VIRTUO connected to MYLA AND Your Blood Culture workflow is based on 2 or more bottles with the same specimen (same specimen/laboratory id) AND You are using the LIS capability to send Blood Culture requests containing the incubation expected duration (MTT) AND You are sending other requests than Blood Culture (Offline SU, ID,) on the same specimen than the one used for BC note: this condition is applicable only if it occurs after the previous ones, chronologically speaking - If the answer to ALL of the above questions is yes, then the customer must contact their bioMerieux representative for help to implement a workaround that should be used until MYLA version 4.9 is available. If the answer to any of the above question is no, the customer will not be impacted by this anomaly. The firm issued an updated Field Safety Corrective Action, FSCA #5308-2, on 9/29/2021 to subsidiaries and distributors which replaced FSCA #5308-1 to revise references in the FSCA document to only include the references of the impacted software. The firm added Annex I to the enclosed customer letter to be issued by the subsidiaries/distributors that provides guidance on how to check the MYLA software version and if BCI connectivity is being used.