BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMérieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.
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 describes a software data integrity issue without reporting any illnesses, injuries, or deaths. Per the rubric, this falls under moderate severity as a low-risk contamination or labeling/data error without reported harm.
Plain-English summary
BioMérieux Inc is recalling 12,384 kits of Vitek 2 Systems Software version 6.01. The software is used with the VITEK 2 automated system for the identification and antimicrobial susceptibility testing of bacteria and yeast. The recall is due to a software issue where the Bidirectional Computer Interface (BCI) antibiotic codes for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly during the upgrade from version 5.xx to 6.01.
The affected software is distributed worldwide, including in the United States and numerous international markets. The issue specifically affects customers who are using software version 6.01 and are interfaced with a Laboratory Information System (LIS). The error results in incorrect firm codes in the reference table for the three specified antibiotics.
Customers using the affected software should contact BioMérieux Inc for further instructions on how to resolve the issue. The recall is limited to the specific software version and configuration described in the notice.
The recalled product
- Product
- bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
- Manufacturer
- Biomerieux Inc
- Affected units
- 12,384
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)
- version 6.01
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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