Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Reason for recall: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. 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, Hung Quantity: N/A Lot/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
15099590701574
Official record: FDA (Device enforcement) ↗
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