Events

Avis De Sécurité sur ARCHITECT Anti-HCV Reagents

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Abbott GmbH & Co. KG..

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
  • Numéro de l'événement
    SN2010(02)
  • Date
    2010-04-15
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/architect-anti-hcv-reagents&id=d98bf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Abbott has determined that s/co values generated with architect anti-hcv (ln 6c37) may decrease when 25% or less of test volume is remaining leading to:  • abbott positive control values shift down and/or out of range low, • non-abbott positive control values shift down and/or out of range low, and/or • a decrease in patient result values.
  • Action
    Abbott has issued a Field Safety Notice (FSN) (March 2010) to all Irish customers using the ARCHITECT Anti-HCV assay recommending customers mix the ARCHITECT Anti-HCV assay diluent (LN 6C37J, green bottle label) prior to testing each day of use.

Device

ARCHITECT Anti-HCV Reagents
  • Modèle / numéro de série
  • Description du dispositif
    ARCHITECT Anti-HCV Reagents
  • Manufacturer
    Abbott GmbH & Co. KG.

Manufacturer

Abbott GmbH & Co. KG.
  • 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
    HPRA