Device Recall VITROS Chemistry Products Calibrator Kit 16

  • Modèle / numéro de série
    Lot 1630
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall: Worldwide Distribution - USA (Nationwide) and the countries of Brazil, Canada, Chile, China, Colombia, England, France, Mexico, Panama, Singapore, Spain, Venezuela.
  • Description du dispositif
    VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA