BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 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 total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.

    Recall: Z-2119-2016 · Initiated May 24, 2016

    Recall

    Recall Number
    Z-2119-2016
    Event Number
    74363
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305841
    Product Code
    JMO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 24, 2016
    Terminated
    June 8, 2018
    Address
    1000 Lee Road, Rochester, NY, 14606

    Description

    VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 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 total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.

    Reason

    Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.

    Action

    Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 24, 2016, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to discontinue using the affected product until Assay Data Diskette (ADD) Data Realease Version (DRV) 5884 or above was installed on their VITROS System. Foreign affiliates were informed of the issue via e-mail on 5/24/2016 and instructed to notify their consignees of the issue and required actions. Customers with questions were advised to contact Ortho's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

    Distribution

    Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela.

    Quantity

    US: 1517; Foreign: 842