Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
FDA device recall Z-0574-06 · posted 2006-02-28 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- May have tobramycin over-recovery at the trough level.
- Action taken
- Consignees were notified via phone and faxed recall letter on or about 2/10/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFW
- Quantity affected
- 1806 kits
- Distribution
- Nationwide.
- Date initiated
- 2006-02-10
- Date posted
- 2006-02-28
- Date terminated
- 2006-06-23
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CEDIA(R) TOBRAMYCIN ASSAY (K912143) | Microgenics Corp. | 1991-07-26 |