FDA-Device2016-11-02Class II
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.
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
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2017Don't want to check this manually?
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