BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux 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. The hazard involves software data integrity errors regarding antibiotic codes, which is a significant functional defect but does not involve direct physical injury or a high-risk pathogen, fitting the Moderate criteria for labeling/data errors.
Plain-English summary
BioMerieux 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 product issue identified in customers using software version 6.01 who are interfaced with a Laboratory Information System (LIS).
During the software update from version 5.xx to 6.01, the Bidirectional Computer Interface (BCI) antibiotic codes for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly. This results in incorrect firm codes in the reference table for these specific antibiotics.
The affected products were distributed worldwide, including the United States and numerous international markets. Users of the affected software version should contact BioMerieux Inc for further instructions on how to resolve the issue.
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 EN. Part number: 414560. 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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