Events

Rappel de ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT

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
    94615
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-03-09
  • 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
    On february 24 2016 a product deficiency was identified. testing performed to investigate complaint ticket 1061060r1715901 (received february 12 2016) confirmed the issue of obtaining the message "no assay" on the architect module display when using the new assay file and testing with architect 2nd generation testosterone reagent kit list number 2p13-28 lot 10458up00. a non-conformance report was opened on 24feb2016. preliminary root cause investigation was performed by tpm axis-shield diagnostics and identified the barcode for this lot was coded with the us assay file number instead of the ous assay file number. the information is hardcoded to the barcode on the microparticle bottle. therefore the customers are unable to test because the ous assay file does not recognize this lot with us assay file. axis shield has both assay files (us and ous) installed on their analyzer which is why the lot passed testing during manufacturing.

Device

ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT

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