BEUDAMED
    FDA Recall Terminated

    Elecsys PreciControl Varia 3

    Recall: Z-2173-2017 · Initiated April 10, 2017

    Recall

    Recall Number
    Z-2173-2017
    Event Number
    77108
    Firm
    Roche Diagnostics Corporation
    FEI Number
    1823260
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 10, 2017
    Posted
    May 31, 2017
    Terminated
    August 4, 2017
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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

    Action

    On 4/10/2017, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected consignees via courier. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

    Distribution

    Nationwide

    Quantity

    1603