BioMérieux Recalls VITEK 2 Compact 15 Software and Reagent Cards
BioMérieux is recalling VITEK 2 Compact 15 software and reagent cards because they may fail to finalize test results after a software update.
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue is a software malfunction preventing test finalization, which is a functional defect rather than a direct physical hazard like injury or death.
Plain-English summary
BioMérieux Inc is recalling 1,866 units of VITEK 2 Compact 15 software and reagent cards (REF numbers 27415 and 27415R). These products are designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The recall affects VITEK 2 Compact 15 and Compact 30 instruments that were previously manufactured or installed with software versions prior to 5.01 and are currently being upgraded to version 8.01.
The recall was initiated because customers reported that some VITEK 2 cards remain in a preliminary status and do not finalize after being ejected from the instrument. This issue also prevents cards in subsequent carousel slots from being processed. The problem was reported to occur following a system software update to version 8.01.
The affected products were distributed worldwide. Consumers and healthcare facilities should contact BioMérieux Inc for further instructions on how to resolve the software issue and ensure proper processing of test cards.
The recalled product
- Product
- VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
- Manufacturer
- Biomerieux Inc
- Affected units
- 1,866
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)
- and currently being upgraded to version 8.01.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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