Events

Rappel de SSP UNITRAY - LOW RESOLUTION CLASS I

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

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
    24968
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-10-21
  • 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
    During an internal complaint investigation for problem report pr#135598 the reactivity assignment in our human oligotyping software (hos) program for a32:04 allele in primer mix pm019e was determined to be incorrect. the catalog and lot numbers of the products listd above have been identified to be affected by the incorrect reactivity assignment. the kits would produce an incorrect low resolution typing or mistyping result of a*02 a*03 alleles when testing a sample which has the a32:04 allele. the user would be unaware of the incorrect type unless they confirm the sample typing by another method therefore this would be considered a mistype.

Device

SSP UNITRAY - LOW RESOLUTION CLASS I
  • Modèle / numéro de série
    Model Catalog: 78600-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78000-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78601-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78001-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 54340D (Lot serial: 038 1391657); Model Catalog: 54340D (Lot serial: 038 1360419); Model Catalog: 54340D (Lot serial: 038 1306788); Model Catalog: 54340D (Lot serial: 038 1249868); Model Catalog: 54310D (Lot serial: 022 1385981); Model Catalog: 54310D (Lot serial: 022 1256853); Model Catalog: 54360D (Lot serial: 029 1395129); Model Catalog: 54360D (Lot serial: 029 1247232); Model Catalog: 54360D (Lot serial: 029 1293558); Model Catalog: 54360D (Lot serial: 029 1306794); Model Catalog: 54360D (Lot serial: 029 1362561)
  • Description du dispositif
    SSP UNITARY - LOW RESOLUTION CLASS I
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION