Agency classClass IIOur severity:High FDA (Devices)·Z-0429-2016·Announced 2015-12-23

bioMerieux Recalls MYLA Software Due to Patient Data Linking Error

bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.

Plain-English summary

bioMerieux, Inc. is recalling MYLA MASTER DVD V4.1 CLI, a computer application used as middleware to interface between laboratory instruments and Laboratory Information Systems (LIS). The recall involves 626 systems distributed worldwide, including across the United States and numerous international locations.

The recall is being conducted because the MYLA software, when connected to a Laboratory Information System and a VITEK 2 system, has the potential to link a test result to an incorrect patient record if the records share the same specimen ID. This error could result in patients receiving test results that do not belong to them.

Healthcare facilities and laboratories using the affected software should contact bioMerieux for instructions on how to resolve the issue. The source text does not specify a corrective action or a deadline for the recall.

The recalled product

Product: MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Laboratory Software
Hazard: data-integrity
mis-labeling
Affected units: 626

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

REF # 417191
Serial number/Software version V4.1 CLI

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Part of a larger recall action

This product is one of 7 recalled by bioMerieux, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · bioMerieux, Inc.

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