BioMerieux SA recalls MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results

Recalled August 18, 2021 · FDA recall Z-2225-2021 · BioMerieux SA

Hazard

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. · FDA Class II

Units

248 systems

Sold at

Distribution in the U.S. was nationwide. There was also military and government distribution.

Description

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

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.

Manufacturer(s)

BioMerieux SA

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →