Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as we
FDA device recall Z-0736-2007 · posted 2007-04-13 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.
- Action taken
- A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
- Root cause
- Other
- Status
- Terminated
- Product code
- KXT
- Quantity affected
- 4,735
- Distribution
- Nationwide.
- Date initiated
- 2007-03-16
- Date posted
- 2007-04-13
- Date terminated
- 2008-06-12
- 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 |
|---|---|---|
| COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C (K851032) | Roche Diagnostic Systems, Inc. | 1985-04-03 |