{ "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": "141769", "product_res_number": "Z-0426-2016", "event_date_initiated": "2015-11-03", "event_date_created": "2015-12-16", "recall_status": "Terminated", "event_date_terminated": "2017-12-04", "res_event_number": "72643", "product_code": "JQP", "product_description": "MYLA MASTER DVD 3.2 CLI DL380\r\n\r\nProduct Usage:\r\nMYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).", "code_info": "REF # 415358, Serial number/Software version V3.2 CLI", "firm_fei_number": "3002769706", "recalling_firm": "bioMerieux, Inc.", "address_1": "100 Rodolphe St", "city": "Durham", "state": "NC", "postal_code": "27712-9402", "additional_info_contact": "Ryan LeMELLE\n314-731-8582", "reason_for_recall": "MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.", "root_cause_description": "Software design", "action": "bioMerieux sent an Urgent Product Correction Notice letter dated November10, 2015 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local bioMrieux Clinical Customer Service organization at (800) 682-2666.", "product_quantity": "626 systems in total", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.", "openfda": { "k_number": [ "K833353", "K844907", "K802471", "K780881", "K800724", "K801167", "K761063", "K861779", "K893838", "K831830", "K810968", "K790543", "K830296", "K792129", "K983468", "K821531", "K113007", "K812604", "K801438", "K760739", "K800241", "K810631", "K770671", "K871339", "K823785", "K851321", "K782052", "K802251", "K822146", "K892060", "K953652", "K820427", "K801131", "K821058", "K801091", "K864557", "K934111", "K850659", "K790336", "K801210", "K822932", "K832746", "K822381", "K821807", "K861778", "K810063", "K881194", "K792158", "K801664", "K854265", "K834490", "K861844", "K823110", "K843365", 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