BEUDAMED
    FDA Recall Terminated

    EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.

    Recall: Z-0952-2009 · Initiated October 16, 2008

    Recall

    Recall Number
    Z-0952-2009
    Event Number
    50209
    Firm
    Epocal
    FEI Number
    3004959793
    Product Code
    CEM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 16, 2008
    Posted
    February 6, 2009
    Terminated
    February 6, 2009
    Address
    2935 Conroy Rd, Ottawa Canada

    Description

    EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.

    Reason

    elevated range of potassium levels

    Action

    The recalling firm visited the hospital on 10/18/08 to conduct an investigation. At the end of the visit, the firm representatives removed the remaining cards from the hospital and returned to the manufacturing location.

    Distribution

    Nationwide Distribution --- including state of CA.

    Quantity

    1000 test cards