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Roche Molecular Systems, Inc. recalls The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It i
Recalled December 19, 2012 · FDA recall Z-0490-2013 · Roche Molecular Systems
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. · FDA Class II
Units
855 units.
Sold at
Nationwide Distribution
Description
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Product
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.
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →