BEUDAMED
    FDA Enforcement Class II Terminated

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    Recall: Z-0896-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0896-2022
    Event ID
    89680
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DRG International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 13, 2022
    Initiation Date
    December 21, 2021
    Classification Date
    April 7, 2022
    Termination Date
    February 12, 2024
    Address
    841 Mountain Ave, Springfield, NJ, 07081-3437, United States

    Description

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    Reason

    ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible

    Code Info

    Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31

    Distribution

    NY

    Quantity

    3 Kits