Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
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-0996-04
- Quantity
- 14
- 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 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.
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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