BEUDAMED
    FDA Recall Terminated

    ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

    Recall: Z-2164-2012 · Initiated July 5, 2012

    Recall

    Recall Number
    Z-2164-2012
    Event Number
    62503
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 5, 2012
    Posted
    August 8, 2012
    Terminated
    August 20, 2013
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521

    Description

    ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

    Reason

    A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t

    Action

    The firm, Radiometer, sent two "Priority Level: Urgent" letters one dated July 9, 2012 and the other dated July 24, 2012 to its affected customers via FedEx with tracking. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the attached Recall Response Fax Form via fax to 800-736-0601. The letter informed the customers that a local service representative will be contacting them shortly to install a software update that will prevent this from occuring (in the event that you utilize HL7 version 2.5 or intend to at some future date.) If you have any questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt. 4.

    Distribution

    Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.

    Quantity

    1427 ABL 90 Instruments