BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659

    Recall: Z-1226-2020 · Initiated December 16, 2019

    Recall

    Recall Number
    Z-1226-2020
    Event Number
    84654
    Firm
    Ortho Clinical Diagnostics Inc
    FEI Number
    2250051
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2019
    Terminated
    November 12, 2020
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424

    Description

    VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659

    Reason

    Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

    Action

    Ortho Clinical Diagnostics (Ortho) 16 December 2019, customer letter (Ref. CL2019-343) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail.Letter states reason for recall , health risk and provided with required actions depending upon whether VITROS Calibrator Kit 32 was available for use. VITROS Calibrator Kit 32 is available for use in the U.S. therefore the required actions in order to process urine samples on VITROS Na+ Slides are to:calibrate. o discontinue using the calibration for urine sodium (only) obtained using an affected VITROS Calibrator Kit 2 lot until either VITROS Na+ Slide GEN 27 is available and/or GEN 26 performance is updated in mid-late January 2020 (refer to Resolution section). Ortho will expedite 1 sales unit of VITROS Calibrator Kit 32, if needed. Request via Confirmation of Receipt form. o Use an alternate urine sodium method until calibration with VITROS Calibrator Kit 32 is complete. o If no alternate urine sodium method is available for use, consult with your medical director to determine if the urine sodium calibration obtained using an affected VITROS Calibrator Kit 2 lot is acceptable for continued use until: Calibration with VITROS Calibrator Kit 32 is complete or VITROS Na+ Slides GEN 26 performance is updated (refer to Resolution section of the communication). VITROS Calibrator Kit 2 is acceptable to use after this occurs or VITROS Na+ Slides GEN 27 or higher is available. VITROS Calibrator Kit 2 will be acceptable to use. Questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

    Distribution

    Nationwide Foreign: Australia Brazil Canada L3R 4G5 Chile China Colombia India Japan Mexico Singapore United Kingdom France Germany Italy Spain Portugal Poland Russia Denmark Norway Sweden Belgium Netherlands

    Quantity

    39709 units (12734 US and 26975 OUS)