FDAFebruary 22, 2018device
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, ur...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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