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Roche Diagnostics Operations, Inc. recalls cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-a
Recalled November 2, 2016 · FDA recall Z-0108-2017 · Roche Diagnostics Operations
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. · FDA Class II
Units
9014 in total
Sold at
US Nationwide Distribution
Description
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.
Product
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →