Events

Rappel de ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY

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

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
    19761
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-02-06
  • 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
    Siemens healthcare diagnostics has determined through an internal investigation that the assays listed do not align with the representative data published in the instructions for use (ifu) for onboard stability calibration frequency and/or interference. the assays that did not meet the obs and the calibration frequency ifu claims are: microalbumin_2 (ualb_2) alanine aminotransferase (altp5p) lithium (lith) alkaline phosphatase (alpamp) alkaline phosphatase (alpdea) magnesium (mg) magnesium concentrated (mg_c) total protein ii (tp) acetaminophen (acet) immunoglobulin g_2 (igg_2) transferrin (trf) total bilirubin (added to customer notification due to typographical error). the assays that did not meet the interference ifu claims are: alanine aminotransferase (alt) ammonia (amm) carbon dioxide liquid (co2_l) gamma-glutamyl transferase (ggt) high sensitivity c-reactive protein (hscrp) inorganic phosphorus (ip) inorganic phosphorus_concentrated (ip_c) lactate (lac) uric acid_concentrated (ua_c) wide range crp (wrcrp) lithium (lith) alkaline phosphatase (alpamp).

Device

ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Modèle / numéro de série
    Model Catalog: 00141230 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02189346 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03039070 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07371282 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03036926 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02193432 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03056927 (Lot serial: > 10 numbers contact mfg); Model Catalog: 04993452 (Lot serial: > 10 numbers contact mfg); Model Catalog: 01803350 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03051194 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02271328 (Lot serial: > 10 numbers contact mfg); Model Catalog: 06837459 (Lot serial: > 10 numbers contact mfg); Model Catalog: (Lot serial: > 10 numbers contact mfg); Model Catalog: 07989138 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03035814 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07498649 (Lot serial: > 10 numbers contact mfg); Model C
  • Description du dispositif
    ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC