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FDADecember 18, 2014device

Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

03337154692

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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