bioMerieux MYLA Software Recalled for Potential Patient Record Mismatch
bioMerieux is recalling MYLA software due to a potential risk of linking 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 is classified as FDA Class II. The hazard involves a risk of harm (incorrect patient data) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
bioMerieux, Inc. is recalling MYLA MASTER DVD V4.0 CLI software. 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 across the United States and numerous international countries.
The recall is being conducted because MYLA 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 defect could result in laboratory data being associated with the wrong patient.
The affected software is identified by REF # 416546 and Software version V4.0 CLI. Users of this software should contact bioMerieux, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- MYLA MASTER DVD V4.0 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 # 416546
- Serial number/Software version V4.0 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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