Roche Diagnostics Corp.
Roche brand Cardiac Reader.
| Date | Jan 6, 2005 (initiated Dec 3, 2004) |
| Status | Terminated |
| Reason | Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 95 |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000784 | THE CARDIAC READER SYSTEM Roche Diagnostics Corp., May 18, 2000 |