Roche Modular Drive (rchmdlri), analytical laboratory data interface.
This recall has been terminated (originally issued November 29, 2006).
- Company
- Data Innovations, Inc.
- Recall Initiated
- November 3, 2006
- Posted
- November 29, 2006
- Terminated
- June 11, 2015
- Recall Number
- Z-0223-2007
- Quantity
- 56
- Firm Location
- South Burlington, VT
- Official Source
- View on FDA website ↗
Reason for Recall
Software of modular driver may incorrectly report patient results as Quality Control Results
Distribution
Nationwide and Canada.
Lot / Code Info
Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024
Root Cause
Software change control
Action Taken
Data Innovations notified users by email listserv and by letter dated 10/25/06.
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