V-Twin Automated Chemistry Analyzer Recalled for Software Lockup
Vital Scientific N.V. is recalling two V-Twin automated chemistry analyzers in New York because a software lockup prevents the instruments from producing patient 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 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 explicitly states no patient results are produced and does not report any injuries or illnesses, fitting the criteria for a moderate risk where the hazard is a functional failure without reported harm.
Plain-English summary
Vital Scientific N.V. is recalling two units of the V-Twin, Model # 6002-800, automated chemistry analyzer. The recall affects serial numbers 13-3341 and 13-3344, which were distributed in the state of New York. The device is an in-vitro diagnostic instrument intended for clinical use to measure various analytes, including applications in clinical chemistry and therapeutic drug monitoring.
The recall was initiated because the instruments stopped working due to a software lockup. This malfunction prevents the devices from producing patient results. The source text does not report any patient injuries or illnesses associated with this defect.
Healthcare facilities in New York that possess these specific serial numbers should stop using the affected units. Users should contact Vital Scientific N.V. for further instructions on how to resolve the software issue or arrange for a replacement.
The recalled product
- Product
- V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in…
- Manufacturer
- Vital Scientific N.V.
- Affected units
- 2
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)
- Serial #s: 13-3341 and 13-3344
Distribution
Distributed in 1 state:
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