BEUDAMED
    FDA Recall Terminated

    HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.

    Recall: Z-1849-2011 · Initiated October 7, 2010

    Recall

    Recall Number
    Z-1849-2011
    Event Number
    57602
    Firm
    Hemo Cue, Inc.
    FEI Number
    3005104838
    Product Code
    GKR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 7, 2010
    Posted
    March 30, 2011
    Terminated
    June 22, 2011
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    Description

    HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.

    Reason

    Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.

    Action

    Hemocue AB sent Customer Notification "Notice of Medical Device Correction on HemoCue Glucose 201 DM and HemoCue Hb 201 DM Analyzers" dated October 7, 2010, to customers notifying them of incorrect settings on error codes. The corrective action consists of an update of the configuration settings on the the affected HemoCue Glucose 201 DM and Hb 201 DM analyzers that are in the field. The affected units in the field will be corrected in accordance with a rework procedure that has been established by HemoCue AB.

    Distribution

    Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.

    Quantity

    79