{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "215644", "product_res_number": "Z-2572-2025", "event_date_initiated": "2025-08-13", "event_date_posted": "2025-09-17", "recall_status": "Open, Classified", "res_event_number": "97464", "product_code": "GKZ", "k_numbers": [ "K240252" ], "product_description": "UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer\nREF: C11478", "code_info": "UDI: 15099590701574/ Serial Numbers: BB33238,\nBB33239,\nBB42317,\nBC05150,\nBC08198,\nBC10226,\nBC16320,\nBC21392,\nBC23453,\nBC25457,\nBC25465,\nBC30527,\nBC32542,\nBC42721,\nBC42726,\nBC49882,\nBD13219,\nBD41570,\nBD46639,\nBD46643,\nBD46646,\nBE01022,\nBE02044,\nBE02052,\nBE04080,\nBE21222,\nBE24254,\nBE24257,\nBE29334,\nBE31336,\nBE33366,\nBE42455,\nBE42459,\nBE46517,\nBE49539,\nBE49541,\nBF10071,\nBF12126,\nBF12129,\nBF18194,\nBF33377,\nBF40462,\nBG04041,\nBG04042,\nBG04053,\nBG05080,\nBG11182,\nBG11184,\nBG11185,\nBG14195,\nBG14200,\nBG14204,\nBG14208,\nBG16220,\nBG16231,\nBG17238,\nBG17250,\nBG17260,\nBG19283,\nBG20292,\nBG20294,\nBG25395,\nBG25412,\nBG25413,\nBG26435,\nBG40563,\nBG45631,\nBG46635,\nBH04028,\nBH04029,\nBH05051,\nBH19220,\nBH24260,\nBH31328, \nBD46642,\nBG22347,\nBG20307,\nBD46640,\nBC32545", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "additional_info_contact": "Jennifer cHAU\n714-961-5321", "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.", "root_cause_description": "Component change control", "action": "On August 13, 2025, Beckman Coulter initiated a \"Urgent Medical Device Recall\" notification via E-Mail. Beckman Coulter expanded the recall to additional consignees September 25, 2025 Beckman Coulter asked consignees to take the following actions: \n\nFor specimens with a WBC count > 30 x 103 and = 90 x 103 cells/L, follow the actions listed within the customer letter. \n\nFor specimens with a WBC count > 90 x 103 cells/L, follow the actions listed within the customer letter. \n\nTo identify WBC counts > 30 x 103 cells/L, consider implementing decision rules within your Laboratory Information System (LIS), Middleware, or on affected instruments.\n\nConsult your Medical Director to determine if a retrospective review of results is warranted.\n\nBeckman Coulter recommends posting this letter on or near the affected analyzers\n\nPlease share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter.\n\nAcknowledge receipt of the notification.", "distribution_pattern": "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.", "openfda": { "k_number": [ "K883177", "K961623", "K864579", "K083420", "K220031", "K900593", "K855116", "K854368", "K871600", "K030828", "K900802", "K032342", "K943967", "K853304", "K190898", "K960887", "K932030", "K923237", "K950919", "K061616", "K910473", "K071143", "K170353", "K894179", "K051215", "K953116", "K050057", "K954188", "K910834", "K172604", "K002646", "K840195", "K875047", "K884020", "K021241", "K042724", "K953643", "K921567", "K884346", "K030144", "K831271", "K945205", "K770680", "K991605", "K871837", "K020496", "K964856", "K885028", "K914848", "K000611", "K964988", "K904209", "K900276", "K051199", "K890349", "K932530", "K990311", "K180020", "K933475", "K990327", "K972354", "K882612", "K933478", "K060656", "K946335", "K950918", "K911385", "K944127", "K950057", "K901188", "K901187", "K030408", "K980858", "K803219", "K012904", 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"3000203293", "3039523350", "3008425728", "3009092698", "2432235", "1000442352", "1415939" ], "device_name": "Counter, Differential Cell", "medical_specialty_description": "Hematology", "regulation_number": "864.5220", "device_class": "2" } } ] }