BEUDAMED
    FDA Enforcement Class II Terminated

    ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

    Recall: Z-1462-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1462-2017
    Event ID
    76339
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    January 26, 2017
    Classification Date
    March 14, 2017
    Termination Date
    February 20, 2018
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

    Reason

    Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

    Code Info

    The affected analyzers are serial numbers 393-090R0027N001 to present.

    Distribution

    U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.

    Quantity

    9,688