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Roche Diagnostics Corporation recalls cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer
Recalled May 9, 2018 · FDA recall Z-1610-2018 · Roche Diagnostics
Hazard
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. · FDA Class II
Units
1026 total products
Sold at
USA ( nationwide)
Description
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Product
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.
Manufacturer(s)
Roche Diagnostics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →