BEUDAMED
    FDA Recall Terminated

    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

    Recall: Z-1348-2016 · Initiated February 16, 2016

    Recall

    Recall Number
    Z-1348-2016
    Event Number
    73429
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 16, 2016
    Terminated
    May 30, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

    Reason

    The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.

    Action

    On February 16, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification notices to their customers via FedEx overnight courier, e-communications and via USPS. Customers are advised that there is no impact to the results generated with an affected system. As a precaution, your Ortho-trained service representative will contact you to schedule an inspection of the wiring within the system at your facility. Following the inspection, reconfiguration of the wiring on your system will be performed if appropriate. Please store a copy of the notification with your user documentation until the wires within your system(s) are inspected. In addition, complete the receipt form to indicate that you have been informed of this anomaly. Please return the form to Joe Falvo via email at [email protected] or via fax to 1-888-557-3759 or 1-585-453-4110. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311 anytime.

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.

    Quantity

    2,101 Total units (1,043 domestically & 1,058 internationally)