FDA-Device2016-11-02Class II
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.
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 p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0101-2017Don't want to check this manually?
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