FDAJuly 15, 2016device
Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the host.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnostics operationsrocheroche diagnostics
Recall history
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