FDAJuly 15, 2016device

cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are ...

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

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

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