BEUDAMED
    FDA Recall Terminated

    VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    Recall: Z-0848-2015 · Initiated November 6, 2014

    Recall

    Recall Number
    Z-0848-2015
    Event Number
    69791
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305840
    Product Code
    CDT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 6, 2014
    Posted
    December 22, 2014
    Terminated
    February 28, 2017
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    Reason

    Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

    Action

    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please contact OCD's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

    Distribution

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

    Quantity

    USA: 380 units, Foreign: 155 units