Recall Z-0329-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corp.
Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
| Date | Jul 20, 2004 (initiated Dec 29, 2003) |
| Status | Terminated |
| Reason | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. |
| Root cause | Other |
| Action | A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types. |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945915 | AVL OMNI ANALYZER Avl Scientific Corp., Apr 5, 1995 |