| ||Class 2 Recall|
VITEK 2 Compact computer system
||March 25, 2013
||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.
||Manufactured from September, 2004, to present.
595 Anglum Rd
Hazelwood, Missouri 63042-2320
|For Additional Information Contact
||Jeffrey S. Scanlan
|There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
||bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" dated February 20, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Emails were issued by the recalling firm on 2/18/2013 and 2/19/2013 to their subsidiaries and to distributors. Letters began issuing to customers via e-mail on 2/20/2013. Contact bioMerieux Clinical Customer Service at (800) 682-2666 for questions regarding this notice.
|Quantity in Commerce
||For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed
||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.