BEUDAMED
    FDA Enforcement Class II Terminated

    Elecsys PreciControl Varia 3

    Recall: Z-2173-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2173-2017
    Event ID
    77108
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    April 10, 2017
    Classification Date
    May 31, 2017
    Termination Date
    August 4, 2017
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    Elecsys PreciControl Varia 3

    Reason

    e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays

    Code Info

    Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160

    Distribution

    Nationwide

    Quantity

    1603