Biomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
Biomerieux Inc. is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with a Laboratory Information System.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a software interface error regarding antibiotic codes but does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
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, which is designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The recall affects kits with part number 414563.
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 for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly in the reference table.
The affected products were distributed worldwide, including in the United States and numerous other countries. The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall.
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 IT. Part number: 414563. 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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