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 Insight

This FDA Devices action (record #Z-2225-2021) was formally reported on August 18, 2021, with the manufacturer initiating the action on June 22, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. BioMerieux SA is listed as the recalling firm, operating out of Marcy L'Etoile, N/A. Federal records indicate 248 systems units are affected.

The documented reason for this recall is: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. Distribution data in the federal record shows the product reached: Distribution in the U.S. was nationwide. There was also military and government distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.