BEUDAMED
    FDA Enforcement Class II Terminated

    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

    Recall: Z-1337-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1337-2022
    Event ID
    90266
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Chromsystems Instruments & Chemicals GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 13, 2022
    Initiation Date
    May 19, 2022
    Classification Date
    July 6, 2022
    Termination Date
    May 15, 2024
    Address
    Am Haag 12, N/A, Grafelfing, N/A, N/A, Germany

    Description

    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

    Reason

    Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

    Code Info

    Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865

    Distribution

    US: NY, OH, CT.

    Quantity

    1457 units