Roche brand Cardiac Reader.
FDA device recall Z-0383-05 · posted 2005-01-06 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
- Action taken
- User hospitals were notified via phone, letter and fax (beginning on 12/3/04) a copy of the recall notification on December 3, 2004, which instructed them to immediately cease using the device. The firm issued a press release on December 8, 2004.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 95
- Distribution
- United States.
- Date initiated
- 2004-12-03
- Date posted
- 2005-01-06
- Date terminated
- 2005-09-08
- 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 |
|---|---|---|
| THE CARDIAC READER SYSTEM (K000784) | Roche Diagnostics Corp. | 2000-05-18 |