BEUDAMED
    FDA Recall Terminated

    i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    Recall: Z-0593-2011 · Initiated September 20, 2010

    Recall

    Recall Number
    Z-0593-2011
    Event Number
    56832
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 20, 2010
    Posted
    December 10, 2010
    Terminated
    January 28, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    Reason

    i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.

    Action

    Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed. Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action. Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.

    Distribution

    Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Kong, India, Ireland, Israel, Japan, Kingdom of Saudi Arabia, Korea, Kuwait, Mauritius, Mexico, Nigeria, Norway, Panama, Paraguay, Peoples Republic of China, Peru, Poland, Portugal, Qatar, Russia, Singapore, South Africa, Spain, Sweden, UK, Sultanate of Oman, Switzerland, Taiwan, R.O.C., Thailand, Turkey, UAE, Uruguay, and Yemen.

    Quantity

    06F16-05: 45; 06F16-10: 22289; 310000: 4393; 310001: 1139; 310002: 11489.