BEUDAMED
    FDA Enforcement Class II 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 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1464-2015
    Event ID
    70773
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diasorin Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 16, 2015
    Classification Date
    April 20, 2015
    Termination Date
    September 15, 2015
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536, United States

    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.

    Code Info

    131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.

    Distribution

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

    Quantity

    451 kits