BEUDAMED
    FDA Enforcement Class II Ongoing

    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

    Recall: Z-1016-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1016-2023
    Event ID
    91344
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Future Diagnostics Solutions B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 6, 2022
    Classification Date
    January 25, 2023
    Address
    Nieuweweg 279, N/A, Wijchen, N/A, N/A, Netherlands

    Description

    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

    Reason

    Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

    Code Info

    Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636

    Distribution

    Worldwide distribution. US states of AZ, CA, CO, LA, OH, PA, and TX; Austria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom

    Quantity

    342 kits