BEUDAMED
    FDA Enforcement Class II 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 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2164-2012
    Event ID
    62503
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    July 5, 2012
    Classification Date
    August 8, 2012
    Termination Date
    August 20, 2013
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521, United States

    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

    Code Info

    Part Number: 393-090, all production runs, 393-090R0026N0010 to 393-090R0179N010

    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