{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "84537", "product_res_number": "Z-0050-2012", "event_date_initiated": "2009-03-05", "event_date_posted": "2011-10-17", "recall_status": "Terminated", "event_date_terminated": "2012-04-27", "res_event_number": "53046", "product_code": "JHI", "k_numbers": [ "K023480" ], "product_description": "Access Immunoassay Systems Total hCG.\n\nThe Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and plasma using the Access Immunoassay Systems.", "code_info": "Lot Numbers 824542 and 825652.", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "200 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6208", "additional_info_contact": "Melina Cimler, Ph.D.\n714-993-5321", "reason_for_recall": "The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision.", "root_cause_description": "Nonconforming Material/Component", "action": "The recall communication was initiated on March 18, 2009 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter dated March 13, 2009 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems total hCG. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the reagent lot numbers 824542 and 825652, and discard any unused reagent packs.\n\nCustomers were asked to review their historical records for low level quality control to ensure that the assay performance for the referenced lot numbers has been within their laboratory specifications. They were also asked to share the information with their laboratory staff and retain the letter for their Quality System documentation, and then complete and return the enclosed response form within 10 days so that they may be assured that consignees received the notification.\n\nFinally they were told to contact Customer Technical Support Center at 1-800-854-3633 in the US and Canada, or their local Beckman Coulter Representative with any questions.", "product_quantity": "14,764", "distribution_pattern": "Worldwide Distribution -- US, Algeria, Angola, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, canada, Chile, China, Colombia, Czech Republic, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Zambia.", "openfda": { "k_number": [ "K203272", "K926500", "K954993", "K033297", "K820321", "K881015", "K863861", "K781794", "K895809", "K990741", "K871700", "K951136", "K874033", "K914253", "K112315", "K012559", "K021386", "K972742", "K102175", "K812461", "K920505", "K980531", "K860542", "K013702", "K981770", "K991741", "K841023", "K955353", "K841525", "K953383", "K812156", "K830203", "K870106", "K894941", "K872130", "K010522", "K942464", "K852760", "K772039", "K881005", "K843795", "K963231", "K810215", "K003856", "K951705", "K881595", "K011550", "K973957", "K822520", "K925303", "K820271", "K913122", "K973841", "K882155", "K810936", "K872730", "K760336", "K873524", "K822152", "K964633", "K781733", "K831264", "K881355", 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