BEUDAMED
    FDA Recall Terminated

    Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roche Diagnostics Corporation, Indianapolis, IN

    Recall: Z-0379-2008 · Initiated November 14, 2007

    Recall

    Recall Number
    Z-0379-2008
    Event Number
    45805
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 14, 2007
    Posted
    December 29, 2007
    Terminated
    September 22, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roche Diagnostics Corporation, Indianapolis, IN

    Reason

    High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.

    Action

    Consignees were notified of this recall by an Urgent Medical Device Recall letter sent on 11/14/07. The letter instructed the users to immediately discontinue use of Ammonia/ Ethanol/CO2 Control N and Ammonia/Ethanol/CO2 Control A (with listed lots) for quality control assessment of the bicarbonate assay. They were informed that controls may still be used to assess ammonia and ethanol, but alternative controls must be used for assessment of the bicarbonate assay. Consignees are instructed to destroy products at their facility. Consignees were notified of the availability of replacement product via letter dated .

    Distribution

    Nationwide Distibution

    Quantity

    1,296