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Roche Diagnostics Corporation recalls Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyze
Recalled May 9, 2018 · FDA recall Z-1611-2018 · 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<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.
Manufacturer(s)
Roche Diagnostics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →