V-Twin In Vitro Diagnostic Instruments Recalled for Sample Mismatch Risk
Vital Scientific N.V. is recalling 732 V-Twin instruments in New York due to a risk of aspirating samples from the wrong container, which could lead to incorrect patient reports.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the agency classification is Class II without explicit hospitalization reports, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Vital Scientific N.V. is recalling 732 V-Twin in vitro diagnostic (IVD) instruments, specifically reference numbers 6002-800 and 6002-850, distributed in New York. The recall affects serial numbers ranging from 3-3021 to 18-3345 for the 6002-800 model and from 3-3006 to 9-4037 for the 6002-850 model.
During in-house testing, it was determined that there is a possibility the instrument may aspirate a sample from the wrong sample container during a run. This error could result in a mismatch between the sample result and the patient ID. If this error is not detected, it may lead to an incorrect patient report.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself, nor does it report any specific illnesses or injuries resulting from this defect.
The recalled product
- Product
- V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
- Manufacturer
- Vital Scientific N.V.
- Affected units
- 732
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)
- (OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345
- (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037
Distribution
Distributed in 1 state:
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