Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 0499861800
FDA device recall Z-0866-2008 · posted 2008-08-13 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Possible mismatch between patient and result.
- Action taken
- Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 11 of all models
- Distribution
- Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
- Date initiated
- 2008-03-21
- Date posted
- 2008-08-13
- Date terminated
- 2009-11-18
- 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 |
|---|---|---|
| BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239) | Boehringer Mannheim Corp. | 1995-09-25 |