medical Class II Updated 2021-08-18

BioMerieux SA recalls MYLA software. Used to manage microbiology test workflow fr

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
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