The Recall Desk
HighFDA (Devices)·Z-0426-2016·Announced 2015-12-23

bioMerieux MYLA Software Recall for Potential Patient Record Mismatch

bioMerieux is recalling MYLA software due to a potential risk of linking 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 involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

bioMerieux, Inc. is recalling MYLA MASTER DVD 3.2 CLI DL380, 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 defect could result in inaccurate patient data being associated with laboratory results.

Healthcare facilities and laboratories using this software should contact bioMerieux, Inc. for instructions on how to address the issue. The source text does not specify a particular corrective action or timeline for the recall.

The recalled product

Product
MYLA MASTER DVD 3.2 CLI DL380 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 # 415358
  • 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 →

Related recalls

Same manufacturer · bioMerieux, Inc.

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