Events

Rappel de UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECKMAN COULTER CANADA L.P..

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
    62301
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-10-25
  • 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
    Beckman coulter has determined that specific access ostase calibrator and qc lots do not meet their expiration date claims within our 10% criteria. for these lots we determined that ref b83876 and b83877 have 68 days of stability and ref 37305 and 37309 have 51 days of stability. access ostase calibrator and qc instability could result in falsely elevated patient results or qc failures. for 37305/37309 the instability could cause patient results to be overestimated by as much as 16% at the original expiration dates. for b83876/b83877 the instability could cause patient results to be overestimated by as much as 16% as of october 17 2016.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY
  • Modèle / numéro de série
    Model Catalog: 37309 (Lot serial: 628296); Model Catalog: 37309 (Lot serial: 628297); Model Catalog: 37305 (Lot serial: 628297); Model Catalog: 37305 (Lot serial: 628294); Model Catalog: 37305 (Lot serial: 628296); Model Catalog: 37309 (Lot serial: 628294); Model Catalog: B83877 (Lot serial: 626001); Model Catalog: B83877 (Lot serial: 623208); Model Catalog: B83876 (Lot serial: 623207); Model Catalog: B83876 (Lot serial: 626000)
  • Description du dispositif
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY;ACCESS SYSTEM - OSTASE ASSAY;UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY;ACCESS OSTASE QC;ACCESS OSTASE CALIBRATORS
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.