BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY

    Recall: Z-2214-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2214-2014
    Event ID
    68840
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    July 15, 2014
    Classification Date
    August 14, 2014
    Termination Date
    May 21, 2018
    Address
    1000 Lee Road, N/A, Rochester, NY, 14606, United States

    Description

    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY

    Reason

    Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.

    Code Info

    Lots 0168 and 0169

    Distribution

    Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

    Quantity

    5906 total: 240 (US); 5666 (OUS)