FDA Recall
Terminated
PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
Recall: Z-0438-03
·
Initiated December 16, 2002
Recall
- Recall Number
- Z-0438-03
- Event Number
- 25169
- Firm
- Roche Diagnostics Corp.
- FEI Number
- 1823260
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 16, 2002
- Posted
- January 23, 2003
- Terminated
- March 19, 2003
- Address
- 9115 Hague Road, Indianapolis, IN, 46250-0457
Description
PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
Reason
Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
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.
Distribution
United States
Quantity
695