FDA-Device2016-11-02Class II
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.
Roche Diagnostics Operations, Inc.
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.
Sold states
US Nationwide Distribution
Affected count
9014 in total
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2017Don't want to check this manually?
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