BEUDAMED
    FDA Enforcement Class II Ongoing

    Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

    Recall: Z-1857-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1857-2021
    Event ID
    87870
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 23, 2021
    Initiation Date
    April 14, 2021
    Classification Date
    June 15, 2021
    Address
    Akandevej 21, Bronshoj, N/A, Denmark

    Description

    Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

    Reason

    Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

    Code Info

    Model Number: ABL90 FLEX PLUS (393-092) Serial Numbers: ABL90 FLEX PLUS analyzers serial numbers R0214 R0218, and R0223 onwards

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.

    Quantity

    Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.)