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Roche Diagnostics Operations, Inc. recalls VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a
Recalled November 2, 2016 · FDA recall Z-0103-2017 · 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
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →