BEUDAMED
    FDA Recall Terminated

    IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.

    Recall: Z-0042-2012 · Initiated June 7, 2011

    Recall

    Recall Number
    Z-0042-2012
    Event Number
    59891
    Firm
    Exalenz Bioscience Ltd Hamaayan 4 Modiin Israel
    FEI Number
    3005772418
    Product Code
    MSQ
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    June 7, 2011
    Posted
    October 12, 2011
    Terminated
    July 6, 2012

    Description

    IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.

    Reason

    The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted).

    Action

    The firm, Exalenz Bioscience Ltd. notified consignees located in the United States of the recall by telephone, electronic mail, or written correspondence between June 9, 2011 and June 30, 2011. The letter informed consignees that Exalenz will immediately cease marketing the IDkit:HP TWO test in the United States. Consignees were instructed to return shipment of the IDkit:HP TWO test kits that they have in their possession to the companys US warehouse. For question call the VP of North American Sales at 704-770-6162 or VP of Marketing at 617-794-6936.

    Distribution

    Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.

    Quantity

    1240 units