bioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit
bioMerieux is recalling VITEK 2 Systems Software Version 9.01 Update Kits because they may display incorrect organism identification and antimicrobial susceptibility testing results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect diagnostic results (organism identification and AST), which poses a risk of harm to patients through potential misdiagnosis or inappropriate treatment, but the source does not report specific injuries or illnesses.
Plain-English summary
bioMerieux, Inc. is recalling five (5) VITEK 2 Systems Software Version 9.01 Update Kits. The recall is due to a software defect that may cause the VITEK 2 Systems to display incorrect organism identification information and associated Antimicrobial Susceptibility Testing (AST) results when the VITEK 2 FLEXPREP feature is used.
The affected software was distributed nationwide to Colorado, Illinois, Missouri, and Texas. The product is identified by the description "KIT UPDT VTK2 9.01 EN" and the UDI 03573026561260.
Healthcare facilities and users of the VITEK 2 Systems should contact bioMerieux, Inc. for instructions on how to resolve the issue. The source text does not specify a consumer action for the general public, as this is a professional medical device software update.
The recalled product
- Product
- VITEK¿ 2 Systems Software Version 9.01 Update Kit.
- Manufacturer
- bioMerieux, Inc.
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 (2)
- Product Description: KIT UPDT VTK2 9.01 EN
- UDI: 03573026561260
Distribution
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