BEUDAMED
    FDA Enforcement Class II Ongoing

    UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

    Recall: Z-2572-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2572-2025
    Event ID
    97464
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 24, 2025
    Initiation Date
    August 13, 2025
    Classification Date
    September 17, 2025
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

    Reason

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

    Code Info

    UDI: 15099590701574/ Serial Numbers: BB33238, BB33239, BB42317, BC05150, BC08198, BC10226, BC16320, BC21392, BC23453, BC25457, BC25465, BC30527, BC32542, BC42721, BC42726, BC49882, BD13219, BD41570, BD46639, BD46643, BD46646, BE01022, BE02044, BE02052, BE04080, BE21222, BE24254, BE24257, BE29334, BE31336, BE33366, BE42455, BE42459, BE46517, BE49539, BE49541, BF10071, BF12126, BF12129, BF18194, BF33377, BF40462, BG04041, BG04042, BG04053, BG05080, BG11182, BG11184, BG11185, BG14195, BG14200, BG14204, BG14208, BG16220, BG16231, BG17238, BG17250, BG17260, BG19283, BG20292, BG20294, BG25395, BG25412, BG25413, BG26435, BG40563, BG45631, BG46635, BH04028, BH04029, BH05051, BH19220, BH24260, BH31328, BD46642, BG22347, BG20307, BD46640, BC32545

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.

    Quantity

    N/A