medical Class II Updated 2018-05-09

Roche Diagnostics Corporation recalls cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154

Recalled Product

cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 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

Distribution: Nationwide (United States)
Lot/Code Info: Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
View official government recall

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