BEUDAMED
    FDA Recall Terminated

    VersaTREK Myco AS.

    Recall: Z-1540-05 · Initiated August 8, 2005

    Recall

    Recall Number
    Z-1540-05
    Event Number
    33135
    Firm
    Trek Diagnostic Systems
    FEI Number
    1000515493
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 8, 2005
    Posted
    September 14, 2005
    Terminated
    July 21, 2007
    Address
    982 Keynote Cir, Ste 6, Cleveland, OH, 44131-1873

    Description

    VersaTREK Myco AS.

    Reason

    Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.

    Action

    The recalling firm phoned all 13 consignees that the product was distributed to, and sent a recall letter to all 13 consignees, dated August 8, 2005. All 13 consignees have responded back to the recalling firm and have discarded any remaining product that was on hand.

    Distribution

    The product was distributed to consignees located in AL, IA, IL, MD, NJ, OH, PA, Washington D.C. and to two foreign distributors: I.L. Diagnostics, Lago Victoria No. 80, Col. Granada, Mexico D.F., 11520; and Trivitron Diagnostics, #15 4th Street, Abhiramapuram, Chennai, India 600-018.

    Quantity

    29 boxes containing 5 vials in each box.