BEUDAMED
    FDA Enforcement Class II Terminated

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    Recall: Z-0740-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0740-2020
    Event ID
    84123
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 1, 2020
    Initiation Date
    October 14, 2019
    Classification Date
    December 26, 2019
    Termination Date
    November 13, 2020
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424, United States

    Description

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    Reason

    Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.

    Code Info

    Lot with Expiry Date: V6391 2020-02-26 W6895 2020-09-20 X7127 2021-01-17 Y7593 2021-08-28

    Distribution

    Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL.

    Quantity

    2,573