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Terminated

PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.

FDA Recall Z-0438-03 · Posted 2003-01-23

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2002-12-16
Date Terminated2003-03-19
Product Quantity695

Reason for Recall

Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.

Firm 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.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013373OMNI C ANALYZERRoche Diagnostics Corp. · 2001-11-02K990092AVL OMNI MODULAR ANALYZERAvl Scientific Corp. · 1999-01-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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