BEUDAMED
    FDA Recall Terminated

    VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    Recall: Z-1072-2012 · Initiated April 13, 2011

    Recall

    Recall Number
    Z-1072-2012
    Event Number
    60881
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 13, 2011
    Posted
    February 21, 2012
    Terminated
    May 9, 2016
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626

    Description

    VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    Reason

    Ortho Clinical Diagnostics (OCD) received customer complaints regarding the loss of calibration data following the installation of a development Assay Data Disk (ADD) that was available in the on-screen mailbox on the Main Menu System Status screen of their VITROS 5600 Integrated System. OCD's investigation determined that ADD, Data Release Version (DRV) 9241 or 9251 was electronically transferr

    Action

    Ortho-Clinical Diagnostics (OCD) sent an Important Product Correction Notification letters dated April 13, 2011 via FedEx overnight to customers with an affected VITROS 3600 or 5600 System (those not e-Connected). Foreign affiliate consignees were informed of this action via e-mail on April 13, 2011. The letters described the affected products, problem and actions to be followed. The letters states that an OCD Field Engineer will contact customers who has the affected products and perform a Modification (MOD) procedure that will remove ADD DRV 9241 or 9251 from the on-screen mailbox of their system(s). Customers were instructed to complete and return the accompanying Confirmation of Receipt Form and fax to1-888-557-3759 or 1-585-453-4110. The letter asks that distributors forward a copy of the enclosed customer communication to all customers who were shipped an affected VITROS 3600 or 5600 System. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.

    Distribution

    Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela.

    Quantity

    Domestic - 15 units, foreign - 81 units