Agency classClass IIOur severity:High FDA (Devices)·Z-0425-2016·Announced 2015-12-23

bioMerieux MYLA Clinic Patch 3.2.0 CD Recall for Patient Data Linking Error

bioMerieux, Inc. is recalling MYLA Clinic Patch 3.2.0 CD 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 a data integrity error could lead to incorrect patient care, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

bioMerieux, Inc. is recalling 626 systems of MYLA Clinic Patch 3.2.0 CD. This software is a computer application, or middleware, that interfaces between laboratory instruments and Laboratory Information Systems (LIS). The recall covers systems distributed worldwide, including nationwide in the United States and in numerous foreign countries.

The recall is being issued because the MYLA software, when connected to a Laboratory Information System (LIS) 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 that have installed MYLA Clinic Patch 3.2.0 CD should contact bioMerieux, Inc. for instructions on how to resolve the issue. The affected software version is V3.2 CLI, with reference number 414518.

The recalled product

Product: MYLA CLINIC PATCH 3.2.0 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-error
incorrect-patient-linking
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 # 414518
Serial number/Software version V3.2 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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