Recall Z-0086-2021— Roche Diagnostics Operations, Inc.
Class II · Ongoing
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-08-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-08-31
- Firm location
- Indianapolis, IN, United States
Product description
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.