BEUDAMED
    FDA Recall Terminated

    The ABL800 Model#:All

    Recall: Z-1463-2017 · Initiated January 26, 2017

    Recall

    Recall Number
    Z-1463-2017
    Event Number
    76339
    Firm
    Radiometer America Inc
    FEI Number
    3010420736
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 26, 2017
    Terminated
    February 20, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    The ABL800 Model#:All

    Reason

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

    Action

    Customer notification letters were sent 01/27/16. The letter provided the following instructions: The firm recommends that customers ensure that operators and clinicians using the "cord blood sample results from a HIS/LIS or a middleware system to determine treatment are made aware that arterial or venous is not transmitted. An upgraded version of the ABL90 and ABL800 series software will ensure that the full sample type cord blood arterial and cord blood venous will be transmitted to the HIS/LIS or middleware system. The new software version will be installed by local engineer when available. If not the end user customers are instruction to provide a copy of the recall notification letter to the end user. Any questions regarding this letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1.

    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

    17,522