Device 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.
Z-1611-2018
Product summary
- Event
- Event 79676
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1026 total products
- Official record key
device-enforcement:Z-1611-2018
Official wording
Reason: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Code information: Catalog numbers: 3337138001 and 3337138692 UDI: 04015630018321
Distribution pattern: USA ( nationwide)
Derived failure modes
-
Device software or design
software responsible for starting scheduled AutoQC measurements (scheduler) will