Class 2 Device Recall Discovery ULTRA

• Date Initiated by Firm: August 31, 2020
• Create Date: October 08, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0086-2021
• Recall Event ID: 86399
• Product Classification: Slide stainer, automated - Product Code KPA
• Product: DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only); Material Number: 05987750001
• Code Information: All units
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Drew Hodge; 317-521-4343
• Manufacturer Reason for Recall: Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
• FDA Determined Cause: Device Design
• Action: Roche issued Urgent Medical Device Correction letter on 8/31/20 via UPS Ground Receipt stating: reason for recall, health risk and action to take: actions below. " Inform any operators that use the BenchMark ULTRA and DISCOVERY ULTRA instruments of the potential hazards associated with this issue and provide a copy of this notification as appropriate. " Inspect the instrument daily for evidence of leaks (i.e., liquid outside of the waste reservoir, liquid on the floor, liquid on the skin/outer panel of the instrument). " If you experience a fluid leak, stop using the system and turn off the power to the instrument. Immediately contact the Roche Support Network Customer Support Center at 1-800-227-2155. " Complete the attached fax back form (TP-01057) and fax or email it according to the instructions on the form. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference Local Field Engineering Specialists (FESs) will perform specific service actions, including the completion of the Waste Tub and Filter Upgrade (if it has not already been implemented), inspection of specific instrument parts for signs of cracks and fluid leaks, and installation of a power connector shield, which will prevent fluid entry into the power cord connection and socket. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-227-2155 if you have questions about the information contained in this UMDC.
• Quantity in Commerce: 257 (US); 208 (ex-US)
• Distribution: Nationwide Foreign: Canada, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Algeria, Argentina, Aruba, Australia, Bahrain, Bosnia-Herz., Brazil, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Malaysia, Martinque, Mexico, Monaco, Morocco, Namibia, New Caledonia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russia, Saudi Arabia, Singapore, S. Africa, S. Korea, Taiwan, Thailand, Ukraine, UAE, Vietnam
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.