Recall Z-0096-04 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc
Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.
| Date | Nov 6, 2003 (initiated Sep 18, 2003) |
| Status | Terminated |
| Reason | Sample wheel may home to the wrong position. |
| Root cause | Other |
| Action | Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone. |
| Quantity | 154 |
| Distribution | Nationwide and Canada |
| 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 |
| K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc., Oct 4, 2002 |
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc., Mar 10, 1997 |