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Roche Molecular Systems, Inc. recalls DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology
Recalled December 19, 2012 · FDA recall Z-0491-2013 · Roche Molecular Systems
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. · FDA Class II
Units
1,015 units
Sold at
Nationwide Distribution
Description
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Product
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →