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

Recall date

June 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2225-2021

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.