Recall – Microbiology workflow software anomaly

Company: BioMerieux SA
Date of Enforcement Report: 8/18/2021
Class II

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.

Recall Number: Z-2225-2021

REASON

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

RECALLING FIRM/MANUFACTURER

BioMerieux SA on 6/22/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

248 systems

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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