Synchron Systems Lipid Calibrator (HDLD) Part 650218
FDA device recall Z-1153-04 · posted 2004-07-23 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Incorrect units are printed in labeling but not in software.
- Action taken
- Letter was mailed which explains tha the units on the Value Sheet are printed incorrectly. Recall is complete.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIS
- Quantity affected
- 2069
- Distribution
- Nationwide
- Date initiated
- 2003-10-03
- Date posted
- 2004-07-23
- Date terminated
- 2004-08-30
- 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 LIPID CALIBRATOR (K983640) | Beckman Coulter, Inc. | 1998-12-21 |