BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-1893-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1893-2020
    Event ID
    85394
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    April 1, 2020
    Classification Date
    May 5, 2020
    Termination Date
    September 1, 2020
    Address
    100 Abbott Park Rd Bldg Ap8b, N/A, Abbott Park, IL, 60064-3502, United States

    Description

    ARCHITECT C Peptide Reagent - 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.

    Code Info

    Lot Numbers 01719F000 (Exp Date 14MAY2020), 02519E000 (Exp Date 09APR2020)

    Distribution

    International distributed only in Mexico, no US distribution.

    Quantity

    65 kits total