Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modul
FDA device recall Z-1352-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- A design change in the electrodes will result in incorrect potassium level results.
- Action taken
- A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 1970
- Distribution
- Nationwide.
- Date initiated
- 2006-07-14
- Date posted
- 2006-08-03
- Date terminated
- 2007-12-04
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239) | Boehringer Mannheim Corp. | 1995-09-25 |