BEUDAMED
    FDA Recall Terminated

    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.

    Recall: Z-1464-2015 · Initiated March 16, 2015

    Recall

    Recall Number
    Z-1464-2015
    Event Number
    70773
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MLM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 16, 2015
    Posted
    April 20, 2015
    Terminated
    September 15, 2015
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.

    Reason

    Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.

    Action

    DiaSorin sent a Customer Notification Letter" to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete and return the confirmation form to the manufacturer. For questions contact DiaSorin Inc. Product Support at 1-800-328-1482.

    Distribution

    Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.

    Quantity

    451 kits