Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
FDA device recall Z-0996-04 · 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
- 14
- 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENESIS (K953345) | Tecan U.S., Inc. | 1995-11-21 |