FDA (Devices) recall action 86399
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
Roche Diagnostics is recalling BenchMark ULTRA Advanced Staining Systems due to a risk of fluid leaks causing electrical shorts, heat, and fire.
Roche Diagnostics is recalling the DISCOVERY ULTRA Advanced Staining System due to fluid leaks that can cause electrical shorts, heat, and smoke.