Recall Z-0336-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corp.
Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
| 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 |