FDA-Device2012-12-19Class II
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Roche Molecular Systems, Inc.
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Sold states
Nationwide Distribution
Affected count
855 units.
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2013Don't want to check this manually?
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