Biomerieux recalls MYLA software versions 4.7 and : AST filter rules may not apply to results when sending to clinicians. Affected labs should check software version and contact Biomerieux for updates.
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Biomerieux recalls specific versions of its MYLA software (4.7 and 4.8) because AST filter rules might not apply to results when sending them to clinicians. This could lead to incorrect organism identification in lab testing.
The software may not correctly apply AST filter rules to results when sending them to clinicians. This could cause incorrect identification of organisms or antibiotic susceptibility, potentially affecting treatment decisions.
Microbiology laboratory staff using MYLA software versions 4.7 or 4.8 with VITEK MS systems are most at risk. The recall affects labs that use this software for identifying organisms and antibiotic susceptibility testing.
Check if your lab uses MYLA software versions 4.7 or 4.8 with VITEK MS systems. The software connects microbiology instruments to laboratory information systems for identifying organisms and antibiotic susceptibility testing.
Verify your MYLA software version is 4.7 or 4.8 to determine if it's affected.
Reach out to Biomerieux for guidance on updating to a newer version of the software.
The recall is because AST filter rules may not apply to results when sending them to clinicians, which could lead to incorrect organism identification.
Software versions 4.7 and 4.8 are affected.
Contact Biomerieux directly for instructions on updating to a newer version of the software.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1201-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1201-2023 from Biomerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
