Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems

  • Modèle / numéro de série
    Catalog Number: 03260925184; Lot Numbers & Exp. Dates:   1. 21450781, Exp. 08/31/2016 2. 21450887, Exp. 08/31/2016 3. 21451391, Exp. 09/30/2016
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.
  • Description du dispositif
    S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 || Blood Gas and Electrolytes Analyzer; 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, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
  • Source