Roche Diagnostics Corporation recalls Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138
Recalled Product
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 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.
Hazard / Issue
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Issued by
FDA
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