BEUDAMED
    FDA Recall Terminated

    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

    Recall: Z-1894-2020 · Initiated April 1, 2020

    Recall

    Recall Number
    Z-1894-2020
    Event Number
    85394
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 1, 2020
    Terminated
    September 1, 2020
    Address
    100 Abbott Park Rd, Bldg Ap8b, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

    Reason

    Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.

    Action

    Abbott Laboratories notified customers on about 04/01/2020 via Product Recall letter. Instructions included to discontinue use and destroy any inventory of ARCHITECT CPeptide Reagents, Calibrators and Controls listed in the table above according to laboratory procedures. Instructions also included to complete and return the Customer Reply Form and to notify customers if product is further distributed.

    Distribution

    International distributed only in Mexico, no US distribution.

    Quantity

    65 kits total