BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux 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.
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, which typically corresponds to a moderate severity score. The issue involves software data integrity errors rather than direct physical hazards or reported injuries.
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 software used in conjunction with Laboratory Information Systems (LIS).
The recall was initiated because a product issue was identified during the software update from version 5.xx to 6.01. Specifically, the Bidirectional Computer Interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin, and Ceftaroline. This error affects the firm code in the reference table for these specific antibiotics.
The affected software was distributed worldwide, including the United States and numerous international locations. Users of the Vitek 2 automated system who are interfaced with a Laboratory Information System and are using software version 6.01 should contact BioMerieux Inc 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, UPDT V2S 6.01 ES. Part number: 414561. 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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