Device Recall VITEK 2 XL computer system

Manufactured from September, 2004, to present.

Immunology and Microbiology Devices

2

No

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.

VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: || (1) rp5700, Cat. #W0452; || (2) rp5700 (refurbished), Cat. #W0452R; || (3) rp5800 XPE, Cat. 413642; || (4) rp5800 WES7, Cat. #413862; || (5) dc7100 8-port, Cat. #W0441; || (6) dc7100 8-port (refurbished), Cat. #W0441R; || (7) dc7700 8-port, Cat. #W0447; || (8) dc7700 8-port (refurbished), Cat. #W0447R; || (9) dc7800, Cat. #W0449; and || (10) dc7800 (refurbished), Cat. #W0449R. || VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.