{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216446", "product_res_number": "Z-0428-2026", "event_date_initiated": "2025-10-01", "event_date_posted": "2025-11-04", "recall_status": "Open, Classified", "res_event_number": "97730", "product_code": "JJE", "k_numbers": [ "K121790" ], "product_description": "Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer", "code_info": "A71460, UDI/DI 15099590369224, Serial Numbers: 902515, 902529, 902528, 902534, 902526, 902527, 902523, 902522, 902524, 902505, 902578, 902579, 902545, 902530, 902531, 902581, 902504, 902514, 902525, 902535, 902566, 902516, 902518, 902532, 902555, 902558, 902564, 902519, 902521, 902559, 902511, 902549, 902554, 902547, 902582, 902583; \nA30260, UDI/DI 15099590341602, Serial Numbers: 902536, 902541, 902517, 902563, 902565, 902557, 902513, 902507, 902543, 902560, 902562, 902506, 902508, 902574, 902533, 902572, 902540, 902569, 902568, 902577, 902510, 902580, 902567, 902573, 902570, 902571, 902538, 902553, 902552, 902512, 902539, 902561, 902575, 902544, 902542, 902556, 902537, 902509, 902520, 902546, 902548, 902551, 902550, 902576.", "firm_fei_number": "2122870", "recalling_firm": "Beckman Coulter, Inc.", "address_1": "1000 Lake Hazeltine Dr", "city": "Chaska", "state": "MN", "postal_code": "55318-1037", "additional_info_contact": "Ian Pilcher\n952-448-4848", "reason_for_recall": "An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.", "root_cause_description": "Process control", "action": "Beckman Coulter issue an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/01/2025 via USPS and email. The notice explained the issue, potential impact, and requested the following: \nIf Wash PnP and/or Incubator PnP Z-motion errors appear in the analyzer event log, take the following steps:\n1. Attempt to reinitialize the analyzer:\na. Go to the Diagnostics screen on the User Interface.\nb. Select Initialize System.\n2. If reinitialization is unsuccessful, contact Beckman Coulter Technical Support in your region.\nBeckman Coulter recommends posting this letter on or near the affected analyzers. \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. \nA field service representative will contact your laboratory to schedule a time to replace the affected parts. \nIf you have any questions regarding this notice, please contact our Customer Support Center website: http://www.beckmancoulter.com", "product_quantity": "80 units", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K833448", "K930489", "K840868", "K760642", "K882914", "K890184", "K853699", "K950958", "K873617", "K780388", "K912024", "K840129", "K971761", "K813102", "K040958", "K863840", "K851638", "K942443", "K904219", "K963539", "K872104", "K882081", "K832584", "K843283", "K940289", "K884378", "K885289", "K772344", "K860080", "K802835", "K832115", "K853003", "K872813", "K946090", "K912844", "K832648", "K945135", "K792361", "K073370", "K860021", "K820888", "K933703", "K822465", "K885226", "K940810", "K823386", "K842773", "K853391", 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