BEUDAMED
    FDA Recall Terminated

    Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.

    Recall: Z-2634-2010 · Initiated March 24, 2010

    Recall

    Recall Number
    Z-2634-2010
    Event Number
    55680
    Firm
    ARKRAY USA INC.
    FEI Number
    1832816
    Product Code
    LJX
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 24, 2010
    Posted
    September 30, 2010
    Terminated
    March 8, 2012
    Address
    5182 W 76th St, Minneapolis, MN, 55439-2900

    Description

    Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.

    Reason

    This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling are correct and properly align with 4pH part number D11400 listed on

    Action

    Distributors were sent a Arkray "URGENT: Voluntary Medical Device RECALL " letter dated March 24, 2010. The letter described the problem and the product being recalled. The letter requested the distributors to immediately examine their inventory , quarantine and return the product subject to the recall. If the distributors had further distributed the recalled product, then they were requested to notify the customers of the recall. Arkray enclosed a customer recall letter that the distributors were to use for notifying their customers. Distributors were also contacted by phone on March 24, 2010, and were informed of the recall issue, the product involved, instructed to quarantine the product and to notify their customers.

    Distribution

    FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, IL ISRAEL

    Quantity

    5504