Events

Rappel de ALLSET GOLD SSP HLA CLASS I HIGH RESOLUTION KITS

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
    41514
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-05-18
  • 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
    A false negative reaction may be observed in the presence of a*11:01:04 specifially for primers pm118c pm118f a11-01 and a11-01a. this could lead to mis-typings during analysis.

Device

ALLSET GOLD SSP HLA CLASS I HIGH RESOLUTION KITS
  • Modèle / numéro de série
    Model Catalog: 541100D (Lot serial: Lot 8 Batch 1441210); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1608939); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1608858); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1472871); Model Catalog: 54310D (Lot serial: Lot 22 Batch 63056); Model Catalog: 541100D (Lot serial: Lot 8 Batch 1608856); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1247232); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1293558); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1306794); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1362561); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1395129); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1428078); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1465433); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1508463); Model Catalog: 54360D (Lot serial: Lot 29 Batch 647); Model Catalog: 54360D (Lot serial: Lot 29 Batch 646); Model Catalog: 54360D (Lot serial: Lot 29 Batch 645); Model Catalog: 54360D (Lot serial: Lot 29 Batch 158
  • Description du dispositif
    AllSet Gold SSP HLA Class I High Resolution Kits;AllSet Gold HLA Low Resolution Kits;AllSet Gold ABDRQ Low Resolution Kit;AllSet Gold ABDR Low Resolution Kit;AllSet Gold SSP HLA Direct to High Resolution Kit;AllSet Gold HLA ABC Low - Resolution SSP Kit 10
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC