BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 29, 2016

    Recall

    Recall Number
    Z-2725-2017
    Event Number
    77481
    Firm
    AMS Diagnostics, LLC
    FEI Number
    3009128555
    Product Code
    JIX
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    February 29, 2016
    Address
    1790 N Commerce Pkwy, Weston, FL, 33326-3204

    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.

    Action

    AMS Diagnostics contacted consignees by telephone on 02/29/2017. Representatives advised consignees to discard any recalled product on hand, to be replaced with working product. Customers should not return recalled product to the firm.

    Distribution

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

    Quantity

    9 units