Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia 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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 067 12 17 000
  • Date de mise en oeuvre de l'événement
    2017-12-19
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11901
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Abbott has identified that falsely elevated results may be obtained when using the architect dhea‐s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation.

Device

ARCHITECT DHEA‐S Reagents
  • Modèle / numéro de série
    Product Product Name List Number Lot Number UDI ARCHITECT DHEA‐S Reagents 8K27‐20 01316K000 (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720 01217A000 (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720 02217D000 (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720 04117H000 (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720 ARCHITECT DHEA‐S Reagents 8K27‐25 01216K000 (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725 01117A000 (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725 02217C000 (01) 00380740017453 (17) 180617 (10) 02217C000 (240) 8K2725 02317D000 (01) 00380740017453 (17) 180624 (10) 02317D000 (240) 8K2725 02417D000 (01) 00380740017453 (17) 180624 (10) 02417D000 (240) 8K2725 00517F000 (01) 00380740017453 (17) 180902 (10) 00517F000 (240) 8K2725 02817H000 (01) 00380740017453 (17) 181021 (10) 02817H000 (240) 8K2725
  • Description du dispositif
    IVD Test Reagent/Kits, Immunoassay
  • 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.
  • Représentant du fabricant
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA