The Recall Desk
HighFDA (Devices)·Z-0430-2016·Announced 2015-12-23

bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

What this means for you

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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect patient data) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

bioMerieux, Inc. is recalling MYLA CLI software versions 3.x through 4.1. MYLA is a computer application, or middleware, that interfaces between laboratory instruments and Laboratory Information Systems (LIS). The recall involves 626 systems distributed worldwide, including in the United States and numerous foreign countries.

The recall is due to a potential software defect where MYLA CLI software 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 with the same specimen ID. This error could result in patient data being associated with the wrong individual.

Healthcare facilities and laboratories using the affected software should contact bioMerieux, Inc. for further instructions on how to address the issue. The agency has classified this as a Class II recall.

The recalled product

Product
MYLA CLI V3.X TO V4.1 DL380 SERVER 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
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 # 419071
  • 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 →

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Same manufacturer · bioMerieux, Inc.

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