Events

Alerte De Sécurité sur LeadCare Testing Systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Magellan Diagnostics.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-03-23
  • Date de publication de l'événement
    2018-03-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180323c.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: magellan diagnostics leadcare testing systems (update) the united states food and drug administration (fda) has issued a statement on findings from ongoing investigation into lead testing issues and an updated medical device safety alert concerning leadcare testing systems, manufactured by magellan diagnostics. the fda has conducted investigations with magellan diagnostics as well as becton dickinson (bd), the manufacturer of blood sample collection tubes used alongside with the lead tests, to determine the cause of the inaccurate lead test results from the leadcare testing systems. the fda concluded that there was a significant chance of false results with magellan’s leadcare tests when used with whole blood collected from the vein and stored in certain bd tubes. upon further investigations, bd determined that the affected tubes’ rubber stoppers contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles. this chemical reaction makes it difficult for the magellan lead tests to detect the correct amount of lead in a sample. the fda recommends laboratories and health care professionals take the following actions: discontinue using magellan's leadcare system testing systems with venous blood samples. at this time, all leadcare systems can be used with capillary blood samples. if they are concerned about using the leadcare test systems, the alternative options are mass spectrometry or atomic absorption methods. these are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs. for details, please refer to the fda website: https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm602343.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558988.Htm for information of our previous important safety alert, please refer to mdco website: http://www.Mdco.Gov.Hk/english/safety/recalls/recalls_20170518.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 march 2018.

Device

LeadCare Testing Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Magellan Diagnostics LeadCare Testing Systems (Update)
  • Manufacturer
    Magellan Diagnostics

Manufacturer

Magellan Diagnostics