bioMerieux recalls VITEK 2 Systems Software Version 9.01 Update Kit due to potential incorrect organism identification and antimicrobial susceptibility testing results when using the FLEXPREP feature.
The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.
bioMerieux is recalling a software update kit for VITEK 2 Systems that may show wrong organism identification and antimicrobial test results when using the FLEXPREP feature. This could lead to inaccurate medical treatment decisions if the software is used without proper verification.
The software update may display incorrect identification of bacteria or other organisms and inaccurate antimicrobial susceptibility results when the FLEXPREP feature is used. This could lead to improper treatment decisions if healthcare providers rely on the software without verifying the results.
Healthcare professionals using the VITEK 2 Systems software for antimicrobial testing are most at risk. The recall affects users who have installed the specific software update kit version 9.01.
Check if you have the VITEK 2 Systems Software Version 9.01 Update Kit (UDI: 03573026561260). The product was sold by bioMerieux Inc.
Verify your VITEK 2 Systems software version by checking the product label or documentation.
The VITEK 2 Systems Software Version 9.01 Update Kit may display incorrect organism identification and antimicrobial susceptibility testing results when using the FLEXPREP feature.
The recall does not specify a remedy, so check with bioMerieux Inc for guidance on next steps.
The recall states potential incorrect results, but no serious injury risk is mentioned. The danger level is low_risk.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0639-2019 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0639-2019 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.
