Recall Z-1098-04 ยท EXE Protector, Ostomy
Beckman Coulter Inc
Synchron LX Clinical Systems, Operating Software, All versions.
| Date | Jul 20, 2004 (initiated Oct 10, 2003) |
| Status | Terminated |
| Reason | Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly. |
| Root cause | Other |
| Quantity | 816 |
| 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 |