BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMérieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated properly 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 hazard involves software data integrity errors for specific antibiotic codes, which is a significant quality issue but does not involve direct physical injury or a high-risk pathogen, fitting the Moderate severity criteria for labeling or software errors.
Plain-English summary
BioMérieux Inc is recalling 12,384 kits of Vitek 2 Systems Software version 6.01, used with the VITEK 2 automated system. The software is used for the identification and antimicrobial susceptibility testing of bacteria and yeast. The recall affects the specific media kit V2S 6.01 RP5800-WES7 (Part number: 413861).
The recall is due to a software issue affecting customers who interface the system with a Laboratory Information System (LIS). During the 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. This may result in incorrect data transmission for these specific antibiotics.
The affected software was distributed worldwide, including the United States and numerous international markets. Users of the Vitek 2 automated system with software version 6.01 who utilize LIS interfaces should contact BioMérieux 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, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
- 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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