Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- March 5, 2004
- Posted
- July 20, 2004
- Terminated
- August 7, 2007
- Recall Number
- Z-0997-04
- Quantity
- 8
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.
Distribution
Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
Lot / Code Info
Serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768.
Root Cause
Other
Action Taken
Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.
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