BioMerieux SA Chemin De L'Orme Marcy L'Etoile France 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
Lot Codes / Batch Numbers
MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
Products Sold
MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
BioMerieux SA Chemin De L'Orme Marcy L'Etoile France is recalling MYLA software. Used to manage microbiology test workflow from the reception of requests to the tran due to Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026