SYNCHRON Clinical Systems Enzyme Validator Kit
FDA device recall Z-1378-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- incorrect Calibration Acceptance Limits.
- Action taken
- Recall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 771
- Distribution
- Nationwide & Canada
- Date initiated
- 2004-07-29
- Date posted
- 2004-08-17
- Date terminated
- 2005-02-03
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K984014) | Beckman Coulter, Inc. | 1998-12-23 |