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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 →