Recall Z-0085-2021— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0085-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

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: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001. 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

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

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.