VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (an in vitro diagnostic medical device (IVD))Catalogue Number: 410895Serial Numbers: Lower than #50039, #50050, greater than or equal to #60000ARTG Number: 199422
Model Catalog: 410710 (Lot serial: S/N BELOW 50039 AND ABOVE); Model Catalog: 410895 (Lot serial: 60000 ARE CONCERNED); Model Catalog: 410710 (Lot serial: 60000 ARE CONCERNED); Model Catalog: 410895 (Lot serial: EXCEPTION 50050 IS ALSO); Model Catalog: 410710 (Lot serial: EXCEPTION 50050 IS ALSO); Model Catalog: 410895 (Lot serial: CONCERNED.); Model Catalog: 410710 (Lot serial: CONCERNED.); Model Catalog: 410895 (Lot serial: S/N BELOW 50039 AND ABOVE)
Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.