FDA-Device2012-12-19Class II
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
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
479 units
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0492-2013Don't want to check this manually?
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