Recall Z-0545-03 ยท JGS Electrode, Ion Specific, Sodium
Beckman Coulter Inc
SYNCHRON LX20 AND LX20 Pro
| Date | Feb 5, 2003 (initiated Dec 16, 2002) |
| Status | Terminated |
| Reason | The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence. |
| Root cause | Other |
| Action | Firm will inspect instruments for failure conditions and fix the problem. |
| Quantity | 1001 |
| Distribution | Canada and USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011213 | MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM Beckman Coulter, Inc., May 16, 2001 |
| K014034 | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) Beckman Coulter, Inc., Dec 18, 2001 |
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc., Mar 10, 1997 |