Events

Avis De Sécurité sur ARCHITECT Toxo IgM

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par ABBOTT.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-11-14
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    For the architect toxo igm assay an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for the lot numbers above. these sample types share the commonality of low total igm titer. internal studies with the architect toxo igm assay have shown that pregnant women samples and serum and plasma blood donor samples are not impacted and meet assay specificity claims. .

Device

ARCHITECT Toxo IgM
  • Modèle / numéro de série
    6C20-25 64245LI00 2017-04-12 Not Applicable 66063LI00 2017-05-13 67003LI00 2017-05-12 68443LI00 2017-07-19 69252LI00 2017-07-19 70171LI00 2017-08-26 6C20-35 64248LI00 2017-04-12 66066LI00 2017-05-13 67006LI00 2017-05-12 68444LI00 2017-07-19 69253LI00 2017-07-19 70174LI00 2017-08-26
  • Manufacturer
    ABBOTT

Manufacturer

ABBOTT
  • 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
    AMPMDRS