Roche Diagnostics Corp.
PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
| Date | Jan 23, 2003 (initiated Dec 16, 2002) |
| Status | Terminated |
| Reason | Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results. |
| Root cause | Other |
| Action | An urgent device correction letter dated 12/16/02 was sent to each customer. The letter advised of the problem and instructed customers to follow a strict quality control regime to ensure proper electrode performance. Customers were instructed how to automatically lock the affected parameter so that patient results will not be reported if QC performance violates the customer''s programmed rules. |
| Quantity | 695 |
| Distribution | United States |
| FDA record | Open on fda.gov |