Device Recall VITEK 2 Compact computer system

  • Model / Serial
    Manufactured from September, 2004, to present.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
  • Product Description
    VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: || (1) dc7100 8-port, Cat. #W0441; || (2) dc7100 8-port (refurbished), Cat. #W0441R; || (3) dc7700 8-port, Cat. #W0447; || (4) dc7700 8-port (refurbished), Cat. #W0447R; || (5) dc7800, Cat. #W0449; || (6) dc7800 (refurbished), Cat. #W0449R || (7) rp5700, Cat. #W0452; || (8) rp5700 (refurbished), Cat. #W0452R; || (9) rp5800 XPE, Cat. 413642; || (10) rp5800WES7, Cat. #413862; || (11) d530 6-port, Cat. #W0438; || (12) d530 6-port (refurbished), Cat. #W0438R; and || (13) d530 4-port, Cat. #W0437. || VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Manufacturer Parent Company (2017)
  • Source
    USFDA