Events

Rappel de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - DAT PERFORMANCE VERIFIERS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ORTHO-CLINICAL DIAGNOSTICS.

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
    78604
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-09-21
  • 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
    Ortho clinical diagnostics has initiated this recall due to the potential to obtain lower than expected quality control (qc) results for vitros benz reagent using specific lots of vitros dat performance verifiers. if the issue occurs qc results for benz may be at or below ortho's range of means as defined in the assay sheets. this issue may lead to an inability to verify calibration or cause failures in daily qc results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - DAT PERFORMANCE VERIFIERS
  • Modèle / numéro de série
    Model Catalog: 680 2328 (Lot serial: M5620); Model Catalog: 680 2329 (Lot serial: M5620); Model Catalog: 680 2331 (Lot serial: L5619); Model Catalog: 680 2330 (Lot serial: L5619); Model Catalog: 680 2329 (Lot serial: L5619); Model Catalog: 680 2328 (Lot serial: L5619); Model Catalog: 680 2327 (Lot serial: L5619); Model Catalog: 680 2331 (Lot serial: K5618); Model Catalog: 680 2330 (Lot serial: K5618); Model Catalog: 680 2329 (Lot serial: K5618); Model Catalog: 680 2328 (Lot serial: K5618); Model Catalog: 680 2327 (Lot serial: K5618); Model Catalog: 680 2331 (Lot serial: J5617); Model Catalog: 680 2330 (Lot serial: J5617); Model Catalog: 680 2329 (Lot serial: J5617); Model Catalog: 680 2328 (Lot serial: J5617); Model Catalog: 680 2327 (Lot serial: J5617); Model Catalog: 680 2331 (Lot serial: H5616); Model Catalog: 680 2330 (Lot serial: H5616); Model Catalog: 680 2329 (Lot serial: H5616); Model Catalog: 680 2328 (Lot serial: H5616); Model Catalog: 680 2327 (Lot serial: H5616); Model Catalog: 680 2331 (Lot seri
  • Description du dispositif
    VITROS CHEMISTRY PRODUCTS 5 1 FS CHEMISTRY SYST
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS