The Recall Desk
HighFDA (Devices)·Z-0431-2016·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 involves a risk of harm (incorrect patient data) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

bioMerieux, Inc. is recalling MYLA CLI software versions 3.x to 4.1, a computer application used as middleware to interface between laboratory instruments and 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 patients receiving test results that do not belong to them.

Healthcare facilities and laboratories using the affected software should contact bioMerieux for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MYLA CLI V3.X TO V4.1 ML350 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 # 419072
  • 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 →

Related recalls

Same manufacturer · bioMerieux, Inc.

See all →

Same hazard · data integrity

See all →