PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
FDA device recall Z-0438-03 · posted 2003-01-23 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 695
- Distribution
- United States
- Date initiated
- 2002-12-16
- Date posted
- 2003-01-23
- Date terminated
- 2003-03-19
- 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 |
|---|---|---|
| OMNI C ANALYZER (K013373) | Roche Diagnostics Corp. | 2001-11-02 |
| AVL OMNI MODULAR ANALYZER (K990092) | Avl Scientific Corp. | 1999-01-29 |