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Recall Observatory FDA recall evidence

Device product

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

Z-0547-2020

November 15, 2018

Class II

Product summary

Firm
Vital Scientific N.V.
Event
Event 83910
Status
Ongoing
Classification
Class II
Quantity
732 instruments
Official record key
device-enforcement:Z-0547-2020

Official wording

Reason: During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.

Code information: (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 pattern: NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.