BEUDAMED
    FDA Recall 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 · Initiated July 15, 2014

    Recall

    Recall Number
    Z-2214-2014
    Event Number
    68840
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305841
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 15, 2014
    Posted
    August 13, 2014
    Terminated
    May 21, 2018
    Address
    1000 Lee Road, Rochester, NY, 14606

    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.

    Action

    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification letter dated July 15, 2014,by Federal Express overnight to all affected customers. All US end-user consignees who had been shipped VITROS NH3 DT slides, GEN 59, Product Code 1532589 were informed of the issue. Customers were instructed to: a) use VITROS DT NH3 slides, GEN 59 with Calibration Data Module, Rev. 0168 or 0169 with VITROS DT Calibrator, Lot 42 if available; or b) If VITROS DT Calibrator, lot 42 is not available, the user is instructed to request CDM, Rev. 0170 to be used with VITROS NH3 DT slides, GEN 59 and VITROS DT Calibrator, Lot 44. Customers were instructed to forward this notice if the product was further distributed outside of their facility. OCD has manufactured a new CDM, Rev. 170, containing the necessary data/calibration mathematics for VITROS DT Calibrator, Lot 44 to be used to calibrate VITROS NH3 DT slides, GEN 59. Customers with questions were instructed to call Customers Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

    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)