FDA-Device2012-12-19Class II
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.
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
77 units
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2013Don't want to check this manually?
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