Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160.
FDA device recall Z-1430-04 · posted 2004-09-02 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Action taken
- Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Distribution
- United States.
- Date initiated
- 2004-08-06
- Date posted
- 2004-09-02
- Date terminated
- 2006-06-26
- 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 |