Events

Rappel de INSTRUMENT MANAGER

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

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
    86169
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-11-05
  • 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
    When results of "---.-" are received from the sysmex uf-100 instrument and if the user set the driver configuration option "strip zeros from result" to "yes" all versions prior to v7.00.0006 and v8.00.0005 of the sysu100i driver convert the results to "0.00" in instrument manager. the sysmex uf-100 will send "--.-" when the test has a sample error. all five urinalysis tests performed (rbc wbc ec cast and bact) will be resulted as "0.00" in instrument manager. this could lead to misdiagnosis and mistreatment of a patient.

Device

INSTRUMENT MANAGER
  • Modèle / numéro de série
    Model Catalog: 8.00.0003 (Lot serial: Not applicable); Model Catalog: 8.00.0002 (Lot serial: Not applicable); Model Catalog: 8.00.0004 (Lot serial: Not applicable); Model Catalog: 7.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0002 (Lot serial: Not applicable); Model Catalog: 7.00.0003 (Lot serial: Not applicable); Model Catalog: 7.00.0005 (Lot serial: Not applicable); Model Catalog: 8.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0004 (Lot serial: Not applicable)
  • Description du dispositif
    Instrument Manager Software using the sysu100i driver that connects to the Sysmex UF-100 instrument
  • Manufacturer
    DATA INNOVATIONS LLC

Manufacturer

DATA INNOVATIONS LLC