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-1447-06 · posted 2006-08-29 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Expired product (dated 2006.06) was shipped as replacement for recalled product.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 137 electrodes
- Distribution
- Nationwide.
- Date initiated
- 2006-07-21
- Date posted
- 2006-08-29
- Date terminated
- 2006-11-01
- 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 |