{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124629", "product_res_number": "Z-1828-2014", "event_date_initiated": "2013-11-08", "event_date_posted": "2014-06-20", "recall_status": "Terminated", "event_date_terminated": "2014-12-25", "res_event_number": "67058", "product_code": "GKZ", "k_numbers": [ "K081930", "K120771" ], "product_description": "UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, \nand B24802.\n\nUsed for in vitro diagnostic use in screening patient populations found in clinical laboratories.", "code_info": "All serial numbers", "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": "Dung Nguyen\n714-961-4941", "reason_for_recall": "Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.", "root_cause_description": "Under Investigation by firm", "action": "An Urgent Product Correction letter, dated 11/08/2013, was sent to all the customers who purchased the UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, via phone at (800) 526-7694 in US and Canada. For outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.\n\nBeckman Coulter sent an update on 2/14/14, to inform customers that the recall was expanded to include specific lots of DxH Cleaner.", "product_quantity": "2,874 units total (1696 units in US)", "distribution_pattern": "Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K992875", "K925274", "K770701", "K160429", "K162414", "K032000", "K081890", 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