BEUDAMED
    FDA Enforcement Class II Terminated

    MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.

    Recall: Z-0539-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0539-2021
    Event ID
    86719
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Chromsystems Instruments & Chemicals GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2020
    Initiation Date
    November 2, 2020
    Classification Date
    December 4, 2020
    Termination Date
    December 20, 2021
    Address
    Am Haag 12, N/A, Grafelfing, N/A, N/A, Germany

    Description

    MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.

    Reason

    XXX

    Code Info

    Order No. 0473, Lot No. 2019 (expiration 05/01/2022)

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.

    Quantity

    342 vials