Recall Z-0937-05 ยท CEM Electrode, Ion Specific, Potassium
Beckman Coulter Inc
Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron Family 441104 Electrode Assembly- EL-ISE 445604 Electrode Packaged- EL-ISE
| Date | Jun 28, 2005 (initiated May 20, 2005) |
| Status | Terminated |
| Reason | Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period. |
| Root cause | Other |
| Action | Firm sent letters by US Mail requesting that users discard thier probes. |
| Quantity | 2686 |
| Distribution | United States and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.