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Device Recall VITEK 2 60 computer system
Model / Serial
Manufactured from September, 2004, to present.
Product Classification
Immunology and Microbiology Devices
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 60 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.
Manufacturer
Biomerieux Inc
1 Event
Recall of Device Recall VITEK 2 60 computer system
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Manufacturer
Biomerieux Inc
Manufacturer Address
Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
USFDA
Language
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