BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes were not updated correctly during an upgrade, potentially affecting laboratory reporting.
What this means for you
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue involves software data mapping errors rather than a direct physical hazard or reported injuries, fitting the Moderate severity criteria for labeling or software defects.
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 for the identification and antimicrobial susceptibility testing of bacteria and yeast. The recall affects kits with part number 414538 and the specific update kit UPDT V2S 6.01ML2.
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 for Cefovecin, Prulifloxacin, and Ceftaroline were not updated properly in the reference table.
The affected products were distributed worldwide, including the United States and numerous other countries. Users of the Vitek 2 system who have upgraded to version 6.01 and interface with an LIS should contact BioMerieux for further instructions on resolving the software error.
The recalled product
- Product
- bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
- 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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