BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    Recall: Z-0992-2019 · Reported March 20, 2019

    Enforcement

    Recall Number
    Z-0992-2019
    Event ID
    82113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2019
    Initiation Date
    January 22, 2019
    Classification Date
    March 8, 2019
    Termination Date
    June 10, 2022
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    Reason

    Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

    Code Info

    Lot 4221-0998-3223

    Distribution

    US Distribution to states of: AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.

    Quantity

    1448