BEUDAMED
    FDA Recall Terminated

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    Recall: Z-0009-2010 · Initiated April 27, 2009

    Recall

    Recall Number
    Z-0009-2010
    Event Number
    52202
    Firm
    Biosite Inc
    FEI Number
    1000125596
    Product Code
    DKZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 27, 2009
    Posted
    October 6, 2009
    Terminated
    April 2, 2012
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121

    Description

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    Reason

    The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.

    Action

    Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used. For further information, contact Biosite, Inc. using the following information: Biosite Incorporated, an Inverness Medical Company 9975 Summers Ridge Road San Diego, CA 92121 Phone: 1-877-441-7440, option 2 Fax: 1-858-695-7100 Email: [email protected]

    Distribution

    Nationwide Distribution

    Quantity

    113,575 cups distributed in total