Recalls / —

—#25329

Product

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

510(k) numbers

K013373, K990092

Affected lot / code info

All PO2 electrodes are affected.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern

United States

Timeline

Recall initiated

2002-12-16

Posted by FDA

2003-01-23

Terminated

2003-03-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25329. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.