MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
FDA Recall Z-2225-2021 · Posted None
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Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodeN/A
Date Initiated2021-06-22
Date Terminated2023-02-06
Product Quantity248 systems
Reason for Recall
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Firm Action
bioMerieux in North Carolina issued an 'URGENT PRODUCT CORRECTION NOTICE FSCA 5173-1 - MAY 2021" to their U.S. consignees on 6/22/2021 via email or overnight mail. The notice described the issue and listed the criteria that would result in the MYLA system being impacted.
If all of the criteria are confirmed on the MYLA system, then the system will be impacted by this FSCA and the consignee is instructed to stop using the user scripting rules that change the value in field a4 (Final Category) and update the MYLA application to version 4.8.2.
Root Cause
Software design
Distribution Pattern
Distribution in the U.S. was nationwide. There was also military and government distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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