Recall Z-1378-04 ยท JIX Calibrator, Multi-Analyte Mixture
Beckman Coulter Inc
SYNCHRON Clinical Systems Enzyme Validator Kit
| Date | Aug 17, 2004 (initiated Jul 29, 2004) |
| Status | Terminated |
| Reason | incorrect Calibration Acceptance Limits. |
| Root cause | Other |
| Action | Recall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette. |
| Quantity | 771 |
| Distribution | Nationwide & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984014 | SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 Beckman Coulter, Inc., Dec 23, 1998 |