BEUDAMED
    FDA Recall Open, Classified

    DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

    Recall: Z-0086-2021 · Initiated August 31, 2020

    Recall

    Recall Number
    Z-0086-2021
    Event Number
    86399
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    KPA
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 31, 2020
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

    Reason

    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

    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.

    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

    Quantity

    257 (US); 208 (ex-US)