BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfaced with Laboratory Information Systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text describes a software interface error regarding antibiotic codes but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving potential but not realized harm.
Plain-English summary
BioMérieux Inc is recalling 12,384 kits of Vitek 2 Systems Software version 6.01 (Part number: 414562). The software is used with the VITEK 2 automated system for the identification and antimicrobial susceptibility testing of bacteria and yeast. The recall affects units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because a product issue was 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. Specifically, the firm code in the reference table for these antibiotics is affected.
Customers using the affected software version should contact BioMérieux Inc for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
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 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
- 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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