bioMerieux MYLA Server Software Recalled for Processing Failures
bioMerieux is recalling MYLA V3 server software because it may stop processing data in high-volume settings, requiring remote or on-site service.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no injuries or illnesses are reported, and the hazard is a functional software failure rather than a direct physical safety risk, fitting the criteria for a moderate severity score.
Plain-English summary
bioMerieux, Inc. is recalling 730 units of MYLA V3 computer application software, distributed worldwide. The software is middleware that interfaces between laboratory instruments and Laboratory Information Systems (LIS) on HP Proliant DL380-G8 and ML350-G6 servers.
The recall is due to a performance issue where the MYLA server may slow down or stop processing completely if a task requires more than five minutes to complete. This issue occurs in high-volume settings and impacts the server start-up phase. When the server stops processing, it fails to reboot and requires service, which may be provided remotely or on-site.
Affected users should contact bioMerieux, Inc. for service. The source text does not report any illnesses, injuries, or deaths associated with this software malfunction.
The recalled product
- Product
- MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 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
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 730
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 (1)
- Ref. #415603 and 411402
Distribution
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