Events

Rappel de Device Recall Phadia Prime

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Phadia Ab.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79438
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1276-2018
  • Date de mise en oeuvre de l'événement
    2017-11-20
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162329
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, test, radioallergosorbent (rast) immunological - Product Code DHB
  • Cause
    We want to inform all phadia 250 system operators performing elia assays not to use the function ok to all in any version of phadia prime, up to and including 2.1.4, when rejecting and retesting samples with any elia assay (the ok function may be used for rejecting single tests and dilution of samples in accordance with product dfu).
  • Action
    An urgent recall notification was issued to customers in November of 2017, and informs all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU). For further questions, please call (269) 492-1940.

Device

Device Recall Phadia Prime
  • 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
    Immunology and Microbiology Devices
  • 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
    Phadia Ab

Manufacturer

Phadia Ab
  • Adresse du fabricant
    Phadia Ab, Rapsgatan Plant, Rapsgatan 7, Uppsala Sweden
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA