Recall Z-0224-2007 ยท JQP Calculator/Data Processing Module, For Clinical Use
Data Innovations, Inc.
Roche Cobas driver (rchcob6i), analytical laboratory data interface.
| Date | Nov 29, 2006 (initiated Nov 3, 2006) |
| Status | Terminated |
| Reason | Software of modular driver may incorrectly report patient results as Quality Control Results |
| Root cause | Software change control |
| Action | Data Innovations notified users by email listserv and by letter dated 10/25/06. |
| Quantity | 56 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.