Roche Diagnostics Corporation recalls cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is…

Recall date

February 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1610-2018

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

USA ( nationwide)

Why it was recalled

The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 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, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.