Class 2 Device Recall VITEK 2 XL computer system

• Date Initiated by Firm: February 18, 2013
• Date Posted: March 25, 2013
• Recall Status: Terminated on August 14, 2014
• Recall Number: Z-0990-2013
• Recall Event ID: 64394
• Product Classification: Susceptibility test cards, antimicrobial - Product Code LTW
• Product: 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.
• Code Information: Manufactured from September, 2004, to present.
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: Jeffrey S. Scanlan; 314-731-8694
• Manufacturer Reason for Recall: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
• FDA Determined Cause: Software design
• Action: 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
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.