VITEK 2 Systems Software Issue May Produce Incorrect Antibiotic Test Results
bioMerieux VITEK 2 bacterial identification systems have a software defect where antibiotic susceptibility and synergy test results transmitted to laboratory systems may omit user or automated corrections, potentially leading to incorrect test interpretation.
What this means for you
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: This is a Class II device with a software defect that can result in incorrect test results being transmitted to laboratory information systems. While no patient injuries or illnesses are reported, the risk of incorrect antibiotic susceptibility test results affecting clinical decision-making represents a significant potential for harm.
Plain-English summary
bioMerieux, Inc. has recalled 21,757 VITEK 2 Systems and VITEK 2 with MYLA units distributed in the U.S. and internationally. These systems are used for bacterial identification and antibiotic susceptibility testing in clinical laboratories.
A software defect causes antibiotic screen test and synergy test results sent to Laboratory Information Systems via HL7 format to omit user-corrected or AES-corrected (automated expert system) interpretations. This means the final test results recorded in the laboratory system may not include critical corrections made by laboratory personnel or the system's automated analysis.
The omission of corrected interpretations can lead to incorrect final antibiotic susceptibility or synergy test results being used for clinical decisions. This affects the accuracy of test results that inform antibiotic selection and patient treatment.
The recalled product
- Product
- VITEK 2 Systems and VITEK 2 with MYLA.
- Manufacturer
- bioMerieux, Inc.
- Hazard
- software-defect
- incorrect-test-results
- data-transmission-error
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 (4)
- VITEK 2 - Versions 8.01
- 9.01
- 9.02 (with or without 9MR2)
- 9.03 (with or without #9MR2). VITEK 2 with MYLA - Versions 4.8 and 4.9.
Distribution
Distributed in 1 state:
- NC
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