Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
FDA device recall Z-0332-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Action taken
- A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Distribution
- United States.
- Date initiated
- 2003-12-29
- Date posted
- 2004-07-20
- Date terminated
- 2004-02-20
- 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 |
|---|---|---|
| AVL OMNI ANALYZER (K954018) | Avl Scientific Corp. | 1995-10-05 |
| AVL OMNI ANALYZER (K945915) | Avl Scientific Corp. | 1995-04-05 |