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FDAAugust 31, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

05342716001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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