BEUDAMED
    FDA Enforcement Class III Ongoing

    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    Recall: Z-2725-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2725-2017
    Event ID
    77481
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AMS Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 19, 2017
    Initiation Date
    February 29, 2016
    Classification Date
    July 13, 2017
    Address
    1790 N Commerce Pkwy, Weston, FL, 33326-3204, United States

    Description

    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    Reason

    Lot was not functioning properly and not exhibiting the correct physical properties.

    Code Info

    P/N 5409; Lot No. 15251; Exp. Date 09/2016

    Distribution

    US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.

    Quantity

    9 units