BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly 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 interface error regarding antibiotic codes without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
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 product issue identified for 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 are not updated properly for Cefovecin, Prulifloxacin, and Ceftaroline. For these referenced antibiotics, the firm code in the reference table is affected. The product was distributed worldwide, including the United States and numerous international locations.
Customers using the affected software version should contact BioMérieux for further instructions on how to resolve the interface issue.
The recalled product
- Product
- bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed fo
- 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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