BEUDAMED
    FDA Enforcement Class II Terminated

    ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.

    Recall: Z-2304-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2304-2012
    Event ID
    60514
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sendx Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 5, 2012
    Initiation Date
    June 6, 2012
    Classification Date
    August 30, 2012
    Termination Date
    September 4, 2012
    Address
    1945 Palomar Oaks Way, N/A, Carlsbad, CA, 92011-1300, United States

    Description

    ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.

    Reason

    The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.

    Code Info

    Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers

    Distribution

    Worldwide Distribution - US Nationwide including the state of OH.

    Quantity

    ABL80 FLEX is 1680, ABL80 CO-OX is 1759