BEUDAMED
    FDA Recall 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 · Initiated December 21, 2021

    Recall

    Recall Number
    Z-0896-2022
    Event Number
    89680
    Firm
    DRG International, Inc.
    FEI Number
    2245285
    Product Code
    JKD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 21, 2021
    Terminated
    February 12, 2024
    Address
    841 Mountain Ave, Springfield, NJ, 07081-3437

    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

    Action

    DRG issued letter via email on 12/28/21. Letter states reason for recall, health risk and Action to be taken by distributors and end-users: Please check your inventory for the respective lot, stop using these kits immediately and promptly quarantine these products. Only if you faced above mentioned issue of SO OD <1.2, please ask for replacement of the kits that were affected and provide your data. All unused kits of the affected lot will be replaced.Please reply immediately upon checking your stock/use to this notice to confirm. All replies should be received at once OR by January 7th, 2022. We sincerely apologize for the inconvenience this may have caused you and/or your Customer. Reply to email: [email protected] and copy [email protected].

    Distribution

    NY

    Quantity

    3 Kits