BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.

    Recall: Z-1804-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1804-2014
    Event ID
    68286
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    May 12, 2014
    Classification Date
    June 16, 2014
    Termination Date
    March 23, 2017
    Address
    1000 Lee Road, N/A, Rochester, NY, 14606, United States

    Description

    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.

    Reason

    Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.

    Code Info

    Lots 1732 (exp. 31-Jul-2014), 1743 (exp. 31-Jul-2014), 1753 (exp. 28-Feb-2015), 1764 (31-Jul-2015)

    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

    Domestic - 612 units, Foreign - 461 units