BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0547-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0547-2020
    Event ID
    83910
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vital Scientific N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 4, 2019
    Initiation Date
    November 15, 2018
    Classification Date
    November 22, 2019
    Address
    24, Kanaalweg, Postbus 100, Dieren, N/A, Netherlands

    Description

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

    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 Info

    (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

    NY

    Quantity

    732 instruments