bioMerieux Recalls MYLA Software Due to Patient Data Linking Error
bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.
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 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
bioMerieux, Inc. is recalling MYLA MASTER DVD V4.1 CLI, 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 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 instructions on how to resolve the issue. The source text does not specify a corrective action or a deadline for the recall.
The recalled product
- Product
- MYLA MASTER DVD V4.1 CLI 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.
- 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 # 417191
- Serial number/Software version V4.1 CLI
Distribution
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.
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