BEUDAMED
    FDA Recall Terminated

    Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

    Recall: Z-2673-2011 · Initiated May 11, 2011

    Recall

    Recall Number
    Z-2673-2011
    Event Number
    58878
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 11, 2011
    Posted
    June 27, 2011
    Terminated
    March 15, 2013
    Address
    180 Hartwell Road, Bedford, MA, 01730-2443

    Description

    Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

    Reason

    Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.

    Action

    Instrumentation Laboratories sent a "FIELD SAFETY NOTIFICATION" letter dated April 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. Included with the letter was an upgrade package containing Software V7.2.2 disk along with installation instructions. Also included with the upgrade kit was a Upgrade Tracking Form to be completed and returned via fax at 781-861-4207 or via e-mail at [email protected]. Customers with questions were directed to contact their local representative.

    Distribution

    Worldwide Distribution-- USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE , INDONESIA, ISRAEL, ITALY, JAPAN , KOREA, REPUBLIC OF CHINA, MALAYSIA, NETHERLANDS , PHILIPPINES, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, THAILAND ,TURKEY, and UNITED KINGDOM.

    Quantity

    840 units