Device Recall Omni Microelectrode for cobas b221 analyzer

  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
  • Distribution
    Worldwide Distribution - USA nationwide including PR and the country of Guam.
  • Description du dispositif
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: || 03111873180 as a part of the following systems: || 1. 03337103001, cobas b 221<1>Roche OMNI S1 system || 2. 03337111001, cobas b 221<2>Roche OMNI S2 system || 3. 03337154001,cobas b 221<6>Roche OMNI S6 system || 4. 03337138001, cobas b 221<4>Roche OMNI S4 system || Product Usage: Usage: || Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
  • Manufacturer
  • 1 Event

Fabricant

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