{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189093", "product_res_number": "Z-0117-2022", "event_date_initiated": "2021-07-28", "event_date_posted": "2021-10-14", "recall_status": "Open, Classified", "res_event_number": "88615", "product_code": "CDD", "k_numbers": [ "K110413" ], "product_description": "Power Processor 3K, 3K High Speed Stockyards\n\nModule Nameplate:\nPP 3K Stockyard (Refrig) 9707 REF A88116", "code_info": "Catalog Number:\nA88116 - 3K HS Refrigerated Stockyard\nUDI: 15099590591960\n\nSerial Numbers:\n90HF1304006;\n90HF1306009;\n90HF1303005;\n90HF1508005;\n90HF1302005;\n90HF1610005;\n90HF1806001;\n90HF1209005;\n90HF1303007;\n90HF1708006;\n90HF1205001;\n90HF1805002;\n90HF1402005;\n90HF1503001;\n90HF1104002;\n90HF1208004;\n90HF1208005;\n90HF1203001;\n90HF1012004;\n90HF1101002;\n90HF1702003;\n90HF1402004;\n90HF1303008;\n90HF1210001;\n90HF1207001;\n90HF1305007;\n90HF1305004;\n90HF1610001;\n90HF1505002;\n90HF1307005;\n90HF1610002;\n90HF1508003;\n90HF1210002;\n90HF1306001;\n90HF1206002;\n90HF1208002;\n90HF1305008;\n90HF1009002;\n90HF1101001;\n\n\nCatalog Number:\n6915556 - Power Processor 3K Stockyard (Stockyard 3000/R Kit for PWR PROC)\nSerial Numbers:\n90AM0805001;\n90AM0902009;\n90AM0902005;\n90AM0806003;\n90AM0801003;\n90AM0802002;\n90AM0803001;\n90AM0912002;\n90AM1003002;\n90AM0905010;\n90AM0801004;\n90AM06007008;\n90AM060703;\n90AM060704;\n90AM0710002;\n90AM0905007;\n90AM0710008;\n90AM0903002;\n90AM0808002;\n90AM0711004;\n90AM0711005;\n90AM0810001;\n90AM0901002;\n90AM0905006;\n90AM0904004;\n90AM0904005;\n90AM0803002;\n90AM0710004;\n\nAmended - additional Products and Codes (12/15/2021):\nB05520 - Stockyard, 5K HS, Refrigerated\nSerial Numbers:\n90HG1104002;\n90HG1101001;\n90HG1105002;\n90HG1104001;\n90HG1101003;\n90HG1101002;\n90HG1202004;\n90HG1102005;\n90HG1101004;\n90HG1206002;\n\nA88115 - 5K HS Refrig Stockyard\nSerial Numbers:\n90HG0911001\n90HG0911003\n90HG0911002", "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": "Lindsey Whittaker\n714-961-3614", "reason_for_recall": "Missing splash guard which may expose users to hazardous materials. .", "root_cause_description": "Process control", "action": "During the week of 08/30/2021, the Recalling Firm sent an \"URGENT MEDICAL DEVICE RECALL\" Notification via its Field Action Notification process. On 09/16/2021, the Recalling Firm communicated a updated/revised \"URGENT MEDICAL DEVICE RECALL\" Notification letter which informed customer that, as a result of internal investigations, the Recalling Firm has discovered that the track-level splash guard has not been consistently provided to all customers. This guard is required for safe operation of the Power Processor system and could potentially cause user injuries if the splash guard is not in place.\n\nCustomer are being informed that a Recalling Firm Field Service representative will check their system for the splash guard. if the splash guard is not present, the Field Service representative will order and install it.\n\nCustomers are instructed to:\n1. Continue to follow all safety warnings and system operation information provided in the Instructions for Use.\n2. Share this information with their laboratory staff and to retain this notification as part of their laboratory Quality System documentation.\n3. If customers have forwarded any of the affected products to another laboratory, provide a copy of this notification to them.\n4. To confirm receipt of this Notification, customer are asked to respond within 10 days in one of the following ways:\n-Electronically, if you received this communication via email.\n-Manually, complete and return the enclosed Response Form.\n\nAny questions, contact the Recalling Firm's Customer Support Center or their local representative via website http://www.beckmancoulter.com\n\nUpdate 12/15/2021:\nOn 12/13/2021, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Letter informing of additional products being added to the original Recall initiated in 08/2021 for the missing splash guards. A Recalling Firm's Representative will check the systems and if a splash guard is not present, they will order and install it. In addition, the Recalling Firm is a", "product_quantity": "Total Units=271 units [258 units (3K and 3K HS); 13 units (5K added 12/15/2021)]", "distribution_pattern": "U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA, MI, MS, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WA, and WV\n\nO.U.S.: Canada, China, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Portugal, Qatar, Saudi Arabia, Thailand, Turkey, and Taiwan. Additional O.U.S. added 12/15/2021 - South Africa", "openfda": { "k_number": [ "K854945", "K030655", "K140496", "K060755", "K913646", "K833247", "K110579", "K941235", "K192064", "K971177", "K771047", "K810002", "K760946", "K933142", "K910343", "K760619", "K791216", "K955561", "K813310", "K792460", "K822721", "K160757", "K833142", "K233541", "K781410", "K853127", "K973702", "K813183", "K790347", "K223289", "K883722", "K832710", "K840462", "K133512", "K802220", "K801579", "K060929", "K121314", "K111260", "K013899", "K965186", "K851377", "K093631", "K121946", "K801578", "K973674", "K904776", "K761321", "K782024", "K832717", "K051327", "K151786", "K933315", "K161721", "K853224", "K832711", "K830195", "K832726", "K951134", "K955436", "K984321", "K112443", "K780799", "K090588", "K993571", "K121994", "K924074", "K860815", "K041133", "K792175", "K062467", "K953455", "K190298", "K071224", "K964348", "K172133", "K920078", "K110413" ], "device_name": "Radioassay, Vitamin B12", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1810", "device_class": "2", "registration_number": [ "3015969360", "2432235", "9612316", "8031673", "2182595", "3022178699", "2020726", "3005529799", "3002809144", "3007111389", "3006198300", "3009518015", "1219913", "3011989923", "1036362", "9610126", "2122870", "3005655287", "3002806944", "9680746", "3006677029", "3004192065", "2517506", "8020888", "2032682", "3005094123", "1319681", "3005333358", "2032839", "8032314", "3033967997" ], "fei_number": [ "3002808328", "3015969360", "2432235", "2182595", "3002806559", "3022178699", "2020726", "1000206808", "3005529799", "3002809144", "3007111389", "3006198300", "3009518015", "1219913", "3011989923", "1036362", "3004185580", "2122870", "3005655287", "3002806944", "3003952975", "1000136573", "3006677029", "3004192065", "2517506", "3002808140", "3005094123", "2967", "3005333358", "3007019572", "3033967997" ] } } ] }