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Roche Molecular Systems, Inc. recalls The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software-
Recalled December 19, 2012 · FDA recall Z-0489-2013 · Roche Molecular Systems
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. · FDA Class II
Units
77 units
Sold at
Nationwide Distribution
Description
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Product
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →