Z-0438-03

PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734

Name: Z-0438-03 PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734
Creator: Roche Diagnostics Corp.
Published: 2002-12-16
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2002-12-16 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734 on 2002-12-16. The reason FDA records is "Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0438-03
Status: Terminated
Initiated: 2002-12-16
Posted: 2003-01-23
Terminated: 2003-03-19
Recalling firm: Roche Diagnostics GmbH
Product: PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
Reason for recall: Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
FDA 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 in commerce: 695
Distribution: United States
Product codes and lots: All PO2 electrodes are affected.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)