BEUDAMED
    FDA Enforcement Class II Terminated

    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

    Recall: Z-1336-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1336-2022
    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 I

    Reason

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

    Code Info

    Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841

    Distribution

    US: NY, OH, CT.

    Quantity

    1330 units