Home / Recalls / BioMerieux SA / Z-2225-2021

Z-2225-2021 Class II Terminated

Recalled by BioMerieux SA — Marcy L'Etoile, N/A

Recall Details

Product Type
Devices
Report Date
August 18, 2021
Initiation Date
June 22, 2021
Termination Date
February 6, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
248 systems

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

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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