Events

Alerte De Sécurité sur Remel Streptex Group D Latex Reagent

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

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
    2013-04-09
  • Date de publication de l'événement
    2013-04-09
  • 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_20130409a.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: thermo fisher remelstreptex group d latex reagent medical device manufacturer, thermo fisher scientific issued a medical device safety alert concerning remelstreptex group d latex reagent with model number r30950901 and lot number 1215767. according to the manufacturer,an internal technical investigation has confirmed that streptex group d latex lot: 1215767 sold separately as r30950901 lot: 1215642 and contained within the kits detailed below, may give weak or false negative test results: streptex latex agglutination test (200 tests) r30164701 lot: 1215568 streptex latex agglutination test (50 tests) r30950501 lot: 1215567 streptex latex agglutination test (50 tests) r30950901 lot: 1215642 the positive control reagent continues to react satisfactorily with the latex and will not indicate that the reagent is weak. continued use of these kits may result in false negative test results with some cultures. the manufacturer advises the affected customers to: destroy any remaining stock; contact customer services or local oxoid supplier who will issue a replacement; review results reported using this lot; and consider retesting and/or seek appropriate expert advice. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

Remel Streptex Group D Latex Reagent
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Thermo Fisher RemelStreptex Group D Latex Reagent
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific