BEUDAMED
    FDA Recall Terminated

    VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

    Recall: Z-1648-2014 · Initiated February 20, 2014

    Recall

    Recall Number
    Z-1648-2014
    Event Number
    67643
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    KLI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 20, 2014
    Posted
    May 21, 2014
    Terminated
    April 19, 2017
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

    Reason

    Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.

    Action

    Ortho Clinical Diagnostics sent an Urgent Product Correction Notifications dated February 19, 2014, to all affected customers via Fed Ex and/or US Postal Service Priority Mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to immediately discontinue using and discard all remaining affected product. Customers should review their Quality Control results that were generated using the affected lot. Customers should consult their Laboratory Medical Director if they suspect that patient results were affected. Complete the confirmation of receipt form and return by March 4, 2014. Forward a copy of the Product Correction Notice if the product was distributed outside of your facility. Fax to : 1.888.557.3759 or 1.585.453.4110

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.

    Quantity

    583 units Total (357 units domestically & 226 units internationally)