BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

    Recall: Z-0968-2014 · Initiated October 10, 2013

    Recall

    Recall Number
    Z-0968-2014
    Event Number
    66498
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JRB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 10, 2013
    Posted
    February 10, 2014
    Terminated
    May 18, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

    Reason

    Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.

    Action

    Ortho Clinical Diagnostics sent an Important Product Correction Notification dated October 10, 2013 to all affected customer. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Confirmation of Receipt form. For questions contact the Customer Technical Services at 1-800-421-3311.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain

    Quantity

    6380 units (each unit contains 48 arrays with 10 microcups)