BEUDAMED
    FDA Enforcement Class II Terminated

    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.

    Recall: Z-2493-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2493-2020
    Event ID
    85700
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    May 26, 2020
    Classification Date
    July 4, 2020
    Termination Date
    February 8, 2023
    Address
    Akandevej 21, Bronshoj, N/A, Denmark

    Description

    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.

    Reason

    Potential risk of patient mix-up on analyzers due to software issues.

    Code Info

    Software versions 6.19 and below.

    Distribution

    US - AL, AR, AZ, BM, 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 and WY. OUS - Australia, Austria, Canada, Czech Republic, China, Croatia, Denmark, France, Finland, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom

    Quantity

    4,615 units