BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.

    Recall: Z-0077-2015 · Reported October 22, 2014

    Enforcement

    Recall Number
    Z-0077-2015
    Event ID
    69234
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 22, 2014
    Initiation Date
    September 8, 2014
    Classification Date
    October 16, 2014
    Termination Date
    May 21, 2018
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.

    Reason

    Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

    Code Info

    Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers)

    Distribution

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

    Quantity

    USA: 97; Foreign: 232