BioMérieux Vitek 2 Software Recall Due to Antibiotic Code Errors
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three drugs are not updated correctly when interfaced with laboratory 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 regarding antibiotic codes, which is a moderate risk to diagnostic accuracy but does not involve direct physical injury or high-risk pathogens.
Plain-English summary
BioMérieux Inc is recalling Vitek 2 Systems Software version 6.01 (Part number: 414564). This 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 involves 12,384 total kits.
The recall is due to a software issue affecting customers who interface the system with a Laboratory Information System (LIS). When updating 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 product was distributed worldwide, including the United States and numerous international markets. Users of the affected software version should contact BioMérieux for further instructions on resolving the interface 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 JA. Part number: 414564. 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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