FDA-Device2015-12-23Class II
MYLA CLINIC PATCH 3.2.0 CD 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)).
bioMerieux, Inc.
Hazard
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.
Sold states
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.
Affected count
626 systems in total
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
MYLA CLINIC PATCH 3.2.0 CD 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)).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0425-2016Don't want to check this manually?
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