Events

Rappel de LABTYPE SSO DQA1/DQB1 TYPING TEST

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ONE LAMBDA INC.

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
    107026
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-10-13
  • 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
    Lot specific user documents and catalog files updated for january 2016 nomenclature contain incorrect allele specificity information for certain beads which may result in mistyping. the impacted worksheets and catalog files were released and available for use between the date period july 29 2016 to august 22 2016. only files analyzed during this period are impacted. contact manufacturer for specific lot #s/batch #s and details.

Device

LABTYPE SSO DQA1/DQB1 TYPING TEST
  • Modèle / numéro de série
    Model Catalog: RSO2QT (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSO2Q (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSO2QX (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSO2B1T (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSOH2B1X (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSO2B1 (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSOH2B1X (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSOH2B1T (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSO2B1T (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSSOH2B1 (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSSO2B1 (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSSOH2B1X (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSOH2B1T (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSO2B1T (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSSOH2B1 (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSSO2B1 (Lot serial: LOT 019 VARIOUS BATCH #S); Model C
  • Description du dispositif
    LABTYPE SSO CLASS II DQA1/DQB1 TYPING TEST;LABTYPE SSO CLASS II DRB1 TYPING TEST & LABTYPE HD CLASS II DRB1 TYPING TEST;LABTYPE SSO CLASS I BW4 SUPPLEMENT TYPING TEST;LABTYPE SSO MICA
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC