Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MYLA software. Used to manage microbiology test workflow from the Recalled by BioMerieux SA Due to Software anomaly - Under certain conditions, unwanted alterations...

Date: June 22, 2021
Company: BioMerieux SA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BioMerieux SA directly.

Affected 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.

Quantity: 248 systems

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BioMerieux SA

BioMerieux SA has 45 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report