FDA-Device2021-08-18Class II
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.
BioMerieux SA
Hazard
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Sold states
Distribution in the U.S. was nationwide. There was also military and government distribution.
Affected count
248 systems
Manufactured in
Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, France
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2021Don't want to check this manually?
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