Agency classClass IIOur severity:High FDA (Devices)·Z-0427-2016·Announced 2015-12-23

bioMerieux MYLA Clinic Patch 3.3.0 Recalled for Patient Data Linking Error

bioMerieux is recalling MYLA Clinic Patch 3.3.0 software because it may link test results to incorrect patient records 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 data integrity issues in a clinical setting.

Plain-English summary

bioMerieux, Inc. is recalling MYLA Clinic Patch 3.3.0 CD, a computer middleware application used to interface laboratory instruments with Laboratory Information Systems (LIS). The recall involves 626 systems distributed worldwide, including nationwide in the United States and in numerous foreign countries.

The recall is issued 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 patient data being associated with the wrong individual.

Healthcare facilities and laboratories using this specific software version should verify their system configurations and consult bioMerieux for guidance on resolving the issue. The source text does not specify a remediation method or a deadline for action.

The recalled product

Product: MYLA CLINIC PATCH 3.3.0 CD 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 # 416192
Serial number/Software version V3.3 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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