BEUDAMED
    FDA Enforcement Class III Terminated

    VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740

    Recall: Z-0864-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0864-2017
    Event ID
    75692
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    October 26, 2016
    Classification Date
    December 21, 2016
    Termination Date
    June 22, 2018
    Address
    513 Technology Blvd, N/A, Rochester, NY, 14626-3601, United States

    Description

    VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740

    Reason

    CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.

    Code Info

    Affected Generations (GENs): 3, 11, 12, 30 through 36

    Distribution

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

    Quantity

    124,063 units