BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMerieux Inc is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfacing 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software data integrity issue affecting specific antibiotic codes, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling errors without reported harm.
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 the specific software update kit, part number 414569.
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. This results in incorrect firm codes in the reference table for these specific antibiotics.
The affected software was distributed worldwide, including the United States and numerous international markets. The source text does not specify the exact actions consumers or healthcare facilities should take, nor does it report any illnesses or injuries associated with this software defect.
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 ZH. Part number: 414569. 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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