BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc.

    Recall: Z-0971-2012 · Initiated October 27, 2011

    Recall

    Recall Number
    Z-0971-2012
    Event Number
    60794
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JIT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 27, 2011
    Posted
    February 7, 2012
    Terminated
    February 12, 2016
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626

    Description

    VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc.

    Reason

    Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Reagent.

    Action

    All consignees were sent "Important Product Correction Notification" communications (dated 10/27/11) beginning on 10/27/11 informing them of the issue, and instructing them to discontinue use of their remaining inventory of VITROS Chemistry Products Calibrator Kit 24, VITROS Chemistry Products mALB reagent, and VITROS Chemistry Products mALB Performance Verifiers. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.

    Distribution

    Worldwide Distribution - USA, including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

    Quantity

    4436 units worldwide (domestic - 2201; foreign - 2235)