Phadia Prime

  • Modèle / numéro de série
    Model: , Affected: With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA tests
  • Manufacturer
  • 1 Event

Fabricant

10 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
  • Description du dispositif
    ivd
  • Manufacturer
  • Modèle / numéro de série
    Phadia Prime software 12-4101-00 Phadia 250 12-3900-01  Listed software: EliA dsDNA Well 14-5500-01 EliA U1RNP Well 14-5501-01 EliA Sm Well 14-5502-01 EliA Ro Well 14-5503-01 EliA La Well 14-5504-01 EliA CENP Well 14-5505-01 EliA Scl-70 Well 14-5506-01 EliA Jo-1 Well 14-5507-01 EliA Symphony Well 14-5508-01 EliA RNP70 Well 14-5511-01 EliA GBM Well 14-5514-01 EliA CCP Well 14-5515-01 EliA Celikey IgA Well 14-5517-01 EliA Celikey IgG Well 14-5518-01 EliA Gliadin IgA Well 14-5519-01 EliA Gliadin IgG Well 14-5520-01 EliA Cardiolipin IgA Well 14-5528-01 EliA Cardiolipin IgG Well 14-5529-01 EliA Cardiolipin IgM Well 14-5530-01 EliA B2-Glycoprotein I IgA Well 14-5531-01 EliA B2-Glycoprotein I IgG Well 14-5532-01 EliA B2-Glycoprotein I IgM Well 14-5533-01 EliA PR3S Well 14-5536-01 EliA MPOS Well 14-5537-01 EliA GliadinDP IgA Well 14-5538-01 EliA GliadinDP IgG Well 14-5539-01 EliA RF IgM Well 14-5600-01 EliA RF IgA Well 14-5601-01 EliA SmDP Well 14-5624-01 EliA Scl-70S Well 14-5637-01 EliA anti-TPO Well 14-5641-01 EliA anti-TG Well 14-5642-01 EliA M2 Well 14-5649-01
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR
  • Description du dispositif
    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - instruments, apparatuses and systems
  • Manufacturer
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