Roche Diagnostics Operations, Inc. DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
All units
Products Sold
All units
Roche Diagnostics Operations, Inc. is recalling DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001 due to Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually bu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026