{ "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": "209933", "product_res_number": "Z-0094-2025", "event_date_initiated": "2024-08-28", "event_date_posted": "2024-10-16", "recall_status": "Open, Classified", "res_event_number": "95296", "product_code": "JLW", "k_numbers": [ "K221225" ], "product_description": "The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.", "code_info": "UDI/DI 15099590744373, Lot Numbers: 339117, 338724, 439341, 338367, 338057, 234251", "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": "Courtney Walton\n952-448-4848", "reason_for_recall": "Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.", "root_cause_description": "Under Investigation by firm", "action": "Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via US mail and email. The notice explained the problem, potential impact, requested the discontinuation of use and destruction of the affected product. The notice should be shared with all impacted parties and a retrospective review of patient tests is recommended. \nFor questions regarding this notice, please contact Customer Support Center:\n. From our website: http://www.beckmancoulter.com\n. For customers in the United States, if you need replacement product:\no Call Client Services at 1-800-854-3633", "product_quantity": "2805 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.", "openfda": { "k_number": [ "K902333", "K160647", "K912324", "K813645", "K883726", "K780428", "K864079", "K881381", "K871505", "K921958", "K961629", "K890802", "K831972", "K962216", "K001455", "K832499", "K861920", "K923532", "K862428", "K171103", "K770915", "K931061", "K882907", "K943195", "K832462", "K864839", "K770892", "K792443", "K885157", "K821174", "K904666", "K781170", "K923401", "K914756", "K920856", "K130469", "K802467", "K083844", "K902753", "K843545", "K870245", "K041014", "K903391", "K864134", "K930776", "K062581", "K971780", "K912852", "K851148", "K860288", "K912241", "K820089", "K760255", "K870244", 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