{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217394", "product_res_number": "Z-1221-2026", "event_date_initiated": "2025-11-10", "event_date_posted": "2026-01-30", "recall_status": "Open, Classified", "res_event_number": "97992", "product_code": "GIF", "product_description": "COULTER DxH Diluent, REF 628017\nCOULTER DxH ECO Diluent REF C67250\n\nFor use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers.\nFor use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.", "code_info": "Catalog Numbers:\nCOULTER DxH Diluent, REF 628017\nCOULTER DxH ECO Diluent REF C67250\n\nUDI-DI code: 15099590233686\nLot Numbers:\n2510410\n2510420\n2510450\n3557500\n3557510\n3557540\n3557560\n3557570\n3557640\n3557650\n3557660\n3557670\n3557680\n3557700\n3557710\n3557850\n3557920\n3557930\n3558000\n3558030\n3558040\n3558060\n3558090\n3558100\n3558110\n3558120\n3558140\n3558150\n3558160\n3558170", "firm_fei_number": "3000203293", "recalling_firm": "Beckman Coulter, Inc.", "address_1": "11800 Sw 147th Ave", "city": "Miami", "state": "FL", "postal_code": "33196-2500", "additional_info_contact": "Jennifer Chau\n305-380-4705", "reason_for_recall": "Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.", "root_cause_description": "Under Investigation by firm", "action": "During the week of 11/10/2025, the firm sent via postal and e-mail an \"URGENT MEDICAL DEVICE RECALL\" Letter to customers informing them that Beckman Coulter has confirmed that specific diluent lot numbers of COULTER DxH Diluent and DxH ECO Diluent may contribute to elevated platelet (PLT) Daily Checks background counts cycle when used with the UniCel DxH 600/690T/800/900 analyzers.\n\nCustomers are instructed to:\n\"Check their COULTER DxH Diluent and DxH ECO Diluent inventory against the provided affected lot numbers.\n\"If their lot numbers are NOT affected, continue routine operation and no further action is required.\n\"If their lot numbers are affected, perform a Daily Checks cycle.\no Each container must be individually verified through Daily Checks before use according to the instructions below.\no If Daily Checks pass, continue routine operation and no further action is required, on the active diluent container(s), currently in use.\n\"If the Daily Checks cycle does not pass, follow the instruction provide in the Recall Letter.\n\nFor questions or further assistance - email BECFA@beckman.com", "product_quantity": "76,098 units (US-61843 and OUS-14255)", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.", "openfda": { "k_number": [ "K883990", "K851320", "K873347", "K801346", "K800180", "K790028", "K882490", "K851843", "K760124", "K833972", "K760129", "K882267", "K822325", "K780830", "K840041", "K881130", "K840038", "K840477", "K830188", "K821683", "K833443", "K812309", "K842068", "K850239", "K850095", "K822501", "K831617", "K842929", "K790442", "K883989", "K801357", "K781008", "K844782", "K771787", "K851280", "K840043", "K832116", "K841799" ], "registration_number": [ "3043088937", "3005529799", "3006791549", "1177732", "9610633", "3010421384", "3005333358", "3010725882", "3010188738", "3017237798", "9612316", "1419699", "3005626422", "1319681", "3016014873", "1319808", "3008526732", "2013736", "3009297077", "9613959", "3006949423", "3013660430", "3004910133", "3009711478", "1064608", "1181121", "3007603826", "3027645317", "1000191380", "3016438761", "3043138885", "3002721051", "9610824", "1064130", "3004008703", "2020726", "3009156722", "1061932", "3009963993", "8031673", "3011558129", "3008629785", "3002809144", "2432235", "3000148879", "3004016977", "1034569", "3002806944", "1219913", "2221819", "3008311438", "3048199746", "3004016971", "3008425728", "2243072" ], "fei_number": [ "3043088937", "3005529799", "3006791549", "1177732", "3010421384", "3005333358", "3010725882", "3017237798", "3002806693", "3002684533", "1419699", "3005626422", "3016014873", "3008526732", "2013736", "3009297077", "3013660430", "3006949423", "3004910133", "3009711478", "1181121", "1000136573", "3007603826", "3002806595", "3000203293", "3027645317", "1000191380", "3016438761", "3043138885", "3002808299", "3002721051", "3002808301", "3004008703", "2020726", "3009156722", "3009963993", "3011558129", "3008629785", "3002809144", "2432235", "3000148879", "1000305841", "3004016977", "1034569", "3002806944", "3002808328", "1219913", "2221819", "3008311438", "3003071743", "2967", "3048199746", "3004016971", "3008425728", "2243072" ], "device_name": "Diluent, Blood Cell", "medical_specialty_description": "Hematology", "regulation_number": "864.8200", "device_class": "1" } } ] }