Recall Z-1148-04 ยท JIS Calibrator, Primary
Beckman Coulter Inc
Synchron Systems Prealbumin Reagent Part Number: 475106
| Date | Jul 23, 2004 (initiated May 20, 2003) |
| Status | Terminated |
| Reason | Instability leading to falsely elevated patient results, out of range controls, or error code. |
| Root cause | Other |
| Quantity | 1631 kits |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.