BEUDAMED
    FDA Recall Open, Classified

    ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

    Recall: Z-1321-2022 · Initiated May 18, 2022

    Recall

    Recall Number
    Z-1321-2022
    Event Number
    90286
    Firm
    Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
    FEI Number
    3002807968
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 18, 2022

    Description

    ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

    Reason

    There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

    Action

    On May 20, 2022, Radiometer issued a "Urgent: Medical Device Recall" notification to affected consignees via: Email and FedEx 2nd day Mail. Radiometer ask consignees to take the following actions: 1. For the affected micro measuring modes Radiometer kindly requests you to not use results for cNa+. The most efficient way to ensure this is to remove the parameter from the affected modes as per the procedures included within the letter. 2. Please complete the Recall Response Form and return to your Radiometer representative ([email protected]).

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Bermuda, Canada, Italy, Norway, Austria, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe, China, Croatia, Denmark, Iceland, Germany, Spain, Portugal, India, Brunei, Japan, United Kingdom, Ireland, Russia, Hungary, Australia, New Zealand, Tokelau, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong, Mexico, South Korea, Singapore.

    Quantity

    1489 analyzers