Tecan Clinical Workstations with Robonet software
FDA device recall Z-1022-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Tecan U S Inc
- Reason for recall
- Tecan software has the potential to match the patient with a different patient's test results.
- Action taken
- Consignees were notified by letter on May 3, 2004
- Root cause
- Other
- Status
- Terminated
- Product code
- JQW
- Quantity affected
- 44 units (hardware), 33 units (software)
- Distribution
- CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.
- Date initiated
- 2004-05-03
- Date posted
- 2004-07-20
- Date terminated
- 2005-05-17
- Location
- Durham, NC
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 |