FDA-Device2012-12-19Class II

DataCare POC  is an information management system that provides data management functionality for managing point-of -care 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
126 units
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0493-2013

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