SYNCHRON LX20 AND LX20 Pro
FDA device recall Z-0545-03 · posted 2003-02-05 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.
- Action taken
- Firm will inspect instruments for failure conditions and fix the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- JGS
- Quantity affected
- 1001
- Distribution
- Canada and USA.
- Date initiated
- 2002-12-16
- Date posted
- 2003-02-05
- Date terminated
- 2004-12-01
- 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 |
|---|---|---|
| MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (K014034) | Beckman Coulter, Inc. | 2001-12-18 |
| MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (K011213) | Beckman Coulter, Inc. | 2001-05-16 |
| SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L (K965240) | Beckman Instruments, Inc. | 1997-03-10 |