FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
- Recall number
- Z-0438-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
- Status
- Terminated
- Initiated
- 2002-12-16
- Posted
- 2003-01-23
- Terminated
- 2003-03-19
- 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
- Lot, serial or model codes
- All PO2 electrodes are affected.
- 510(k) numbers
- ["K990092","K013373"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28