Recall Z-1352-06 ยท CEM Electrode, Ion Specific, Potassium
Roche Diagnostics Corp.
Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
| Date | Aug 3, 2006 (initiated Jul 14, 2006) |
| Status | Terminated |
| Reason | A design change in the electrodes will result in incorrect potassium level results. |
| Root cause | Other |
| Action | A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it. |
| Quantity | 1970 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953239 | BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER Boehringer Mannheim Corp., Sep 25, 1995 |