BEUDAMED
    FDA Recall Terminated

    HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134

    Recall: Z-0132-06 · Initiated September 7, 2005

    Recall

    Recall Number
    Z-0132-06
    Event Number
    33515
    Firm
    HemoSense Inc
    FEI Number
    3003038758
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 7, 2005
    Posted
    November 15, 2005
    Terminated
    March 30, 2006
    Address
    651 River Oaks Pkwy, San Jose, CA, 95134-1907

    Description

    HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134

    Reason

    A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.

    Action

    On 9/7/05, the firm issued letters via Federal Express and telephone follow-up to all its consignees, informing them of the affected product and providing instructions on the recall.

    Distribution

    Product was released for distribution to 20 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the users who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

    Quantity

    123 units