BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

    Recall: Z-1179-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1179-2017
    Event ID
    75936
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    December 8, 2016
    Classification Date
    February 9, 2017
    Termination Date
    June 22, 2018
    Address
    513 Technology Blvd, N/A, Rochester, NY, 14626-3601, United States

    Description

    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

    Reason

    There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.

    Code Info

    Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018

    Distribution

    Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

    Quantity

    37,571 packs/90 slides totalling 3,381,390 slides