Events

Alerte De Sécurité sur Captia Malaria EIA Kit

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

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
    2016-07-25
  • Date de publication de l'événement
    2016-07-25
  • 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_20160725a.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: trinity biotech captia malaria eia kit medical device manufacturer, trinity biotech, has issued a medical device safety alert concerning its captia malaria eia kit [product code: 2322470; lot number: 011] while conducting a review of the labeling for the above mentioned kit as part of an investigation, the manufacturer discovered that an incorrect expiration date was assigned to the abovementioned kit lot number. the tmb substrate solution (lot number 523759-506036) that was included in this kit has an expiration date of november 2016. this component expiration should have been considered during the expiration date assignment of this kit lot and therefore the kit has an expiration date of november 2016 and not june 2017 as currently labeled. as the tmb in this kit is still within expiry date, no look back or result review is required on previously release results. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2016.

Device

Captia Malaria EIA Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Trinity Biotech Captia Malaria EIA Kit
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech