Events

Rappel de PHADIA 250 SYSTEM - INSTRUMENT REAGENTS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada 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
    24248
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-03-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    There have been reports of instrument malfunctions for phadia 250 due to deformed bottles in the below mentioned products and lots. the deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent thus generating insufficient dilution of patient samples. the deformation is described as a flange or brim located on the inside lower part of the vial opening. the instrument malfunction due to deformed bottles could cause erroneous test results mainly false positive with regard to all elia assays and mainly falsely increased test results for immunocap total ige and immunocap igg4/igg assays. the frequency of this bottle defect is very low and not every defective bottle will cause the error. an instrument malfunction caused by deformed bottles will generate the instrument error message "3-145 right arm liquid detection below lower limit with target 2". it is important that you review your records for the above mentioned error message.

Device

PHADIA 250 SYSTEM - INSTRUMENT REAGENTS
  • Modèle / numéro de série
    Model Catalog: 83-1023-01 (Lot serial: JM3Y); Model Catalog: 83-1023-01 (Lot serial: JS0B); Model Catalog: 83-1023-01 (Lot serial: JP87); Model Catalog: 83-1023-01 (Lot serial: JK5N); Model Catalog: 83-1023-01 (Lot serial: JU9C)
  • Description du dispositif
    EliA Sample Diluent
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB