DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Reported: December 19, 2012 Initiated: July 16, 2012 #Z-0491-2013
Product Description
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Reason for Recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 1,015 units
- Distribution
- Nationwide Distribution
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.. Recalled by Roche Molecular Systems, Inc.. Units affected: 1,015 units.
Why was this product recalled? ▼
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2012. Severity: Moderate. Recall number: Z-0491-2013.
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