Recall Z-1447-06 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 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
| Date | Aug 29, 2006 (initiated Jul 21, 2006) |
| Status | Terminated |
| Reason | Expired product (dated 2006.06) was shipped as replacement for recalled product. |
| Root cause | Other |
| Action | Consignees were notified by phone and sent a recall letter dated 7/21/06 via fax, which instructed them to discontinue use of these lots of product and to discard them. |
| Quantity | 137 electrodes |
| 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 |