Events

Avis De Sécurité sur ARCHITECT DHEA-S Reagent Kit

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Abbott GmbH & Co.

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
    2017-12-14
  • Date de publication de l'événement
    2018-01-29
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2018/01/29/vazno-obavestenje-o-medicinskom-sredstvu-architect-dhea-s-reagent-kit-imunohemija/
  • Notes / Alertes
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has identified that, when using the architect dhea-s reagent kit, samples from babies up to 60 days of age may have false results. the manufacturer is currently investigating the specific cause of the elevated results. although false elevations have been observed in infants up to 60 days of age, the reference range for children up to 10 years of age given in the test instruction manual should also not be used as the reference ranges are being tested.

Device

ARCHITECT DHEA-S Reagent Kit
  • Modèle / numéro de série
    (8K27-20) 01316K000; 01217A000; 02217D000; 04117H000;(8K27-25)01216K000; 01117A000; 02217C000; 02317D000; 02417D000; 00517F000; 02817H000
  • Manufacturer
    Abbott GmbH & Co

Manufacturer

Abbott GmbH & Co
  • 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
    ALIMSA