Events

Rappel de QUALICHECK 3

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

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
    28157
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-03-21
  • 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
    Radiometer has recently become aware that supplementary inserts for some lots of s7335 (autocheck 3+ level 1) distributed in connection with the release of sofware version 6.16 for the abl800 series analyzers state an incorrect control range for pco2 in "abl810/820/830 sw more than v6.16" column. on the incorrect inserts both the low and high limits are offset by +1.3 mmhg for all affected lots. this also applies to the value in the barcode in the insert. the bar code is used to upload the values to the analyzer.

Device

QUALICHECK 3
  • Modèle / numéro de série
    Model Catalog: S7335 (Lot serial: 0335); Model Catalog: S7335 (Lot serial: 0304); Model Catalog: S7335 (Lot serial: 0333); Model Catalog: S7335 (Lot serial: 0332); Model Catalog: S7335 (Lot serial: 0331); Model Catalog: S7335 (Lot serial: 0330); Model Catalog: S7335 (Lot serial: 0329); Model Catalog: S7335 (Lot serial: 0328); Model Catalog: S7335 (Lot serial: 0327); Model Catalog: S7335 (Lot serial: 0326); Model Catalog: S7335 (Lot serial: 0325); Model Catalog: S7335 (Lot serial: 0324); Model Catalog: S7335 (Lot serial: 0323); Model Catalog: S7335 (Lot serial: 0322); Model Catalog: S7335 (Lot serial: 0321); Model Catalog: S7335 (Lot serial: 0305); Model Catalog: S7335 (Lot serial: 0334)
  • Description du dispositif
    QUALICHECK 3
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS