U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Calculator/data processing module, for clinical use - Product Code JQP
원인
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.
조치
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 bioM¿rieux Clinical Customer Service organization at (800) 682-2666.
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.
제품 설명
MYLA MASTER DVD V4.1 CLI || Product Usage: || MYLA 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)).