Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LX
FDA device recall Z-0096-04 · posted 2003-11-06 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Sample wheel may home to the wrong position.
- Action taken
- Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 154
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-09-18
- Date posted
- 2003-11-06
- Date terminated
- 2004-03-30
- 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 LX I 725 CLINICAL SYSTEM (K023049) | Beckman Coulter, Inc. | 2002-10-04 |
| 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 |