FDAJuly 15, 2016device

cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.

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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