BEUDAMED
    FDA Recall Terminated

    OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076

    Recall: Z-0119-2008 · Initiated July 18, 2007

    Recall

    Recall Number
    Z-0119-2008
    Event Number
    44880
    Firm
    Opti Medical Systems Inc
    FEI Number
    3004102403
    Product Code
    JGS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 18, 2007
    Posted
    November 9, 2007
    Terminated
    December 13, 2007
    Address
    235 Hembree Park Dr, Ste 200, Roswell, GA, 30076-5700

    Description

    OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076

    Reason

    Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.

    Action

    An Urgent Medical Device Recall Letter dated 16 July 2007, was issued via E mail and Fax on/or about 7/18/2007 directing consignees to remove unused cassettes from inventory and destroy them. Replacement cassettes will be shipped upon receipt of information regarding destruction by calling customer service at 800-490-6784. Sub-recall by distributors was requested.

    Distribution

    Worldwide Distribution-USA, Australia, Chile, China, Egypt, France, Great Britain, Guatemala, Indonesia, Italy, Korea, Lebanon, Mauritania, Morocco, Nepal, Russia, South Africa, Sweden, Tanzania, Thailand, and Venezuela.

    Quantity

    289 boxes of 25 cassettes