Events

Rappel de ARCHITECT SYSTEM - HEMOGLOBIN A1C REAGENT KIT

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

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
    53321
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-12-21
  • 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
    It was identified that interference from fetal hemoglobin (hbf) occurs at a level lower than what is stated in the architect hemoglobin alc (ln 4p52-21) package insert. the package insert indicates that the hemoglobin alc (hbalc) assay is susceptible to interference effects from hbf at> 20yo while the most current data shows interference at hbf at >5%. all in-date lots of ln 4p52-21reagent inventory are impacted.

Device

ARCHITECT SYSTEM - HEMOGLOBIN A1C REAGENT KIT
  • Modèle / numéro de série
    Model Catalog: 4P52-21 (Lot serial: 50279UQ12); Model Catalog: 4P52-21 (Lot serial: 50031UQ10); Model Catalog: 4P52-21 (Lot serial: 50030UQ10); Model Catalog: 4P52-21 (Lot serial: 50616UQ02); Model Catalog: 4P52-21 (Lot serial: 50615UQ02); Model Catalog: 4P52-21 (Lot serial: 50614UQ02); Model Catalog: 4P52-21 (Lot serial: 50613UQ02); Model Catalog: 4P52-21 (Lot serial: 50282UQ12); Model Catalog: 4P52-21 (Lot serial: 50007UQ10); Model Catalog: 4P52-21 (Lot serial: 51457UQ08); Model Catalog: 4P52-21 (Lot serial: 51177UQ06); Model Catalog: 4P52-21 (Lot serial: 50884UQ04); Model Catalog: 4P52-21 (Lot serial: 50281UQ12); Model Catalog: 4P52-21 (Lot serial: 50280UQ12)
  • Description du dispositif
    ARCHITECT Hemoglobin A1c
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC