Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001.
FDA device recall Z-0997-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.
- Action taken
- Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQW
- Quantity affected
- 8
- Distribution
- Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
- Date initiated
- 2004-03-05
- Date posted
- 2004-07-20
- Date terminated
- 2007-08-07
- Location
- Indianapolis, IN
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