Events

Alerte De Sécurité sur HemosIL PT-Fibrinogen HS PLUS

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

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
    2014-12-02
  • Date de publication de l'événement
    2014-12-02
  • 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_20141202a.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: instrumentation laboratory hemosil pt-fibrinogen hs plus the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning hemosil pt-fibrinogen hs plus manufactured by instrumentation laboratory. according to the manufacturer, some vials of hemosil pt-fibrinogen hs plus exhibit a yellow/brownish colour after reconstitution instead of the typical white to off-white colour. these vials were observed to cause prolonged prothrombin (pt) clotting times. this issue is attributed to higher levels of residual moisture in some vials. corrective action has been implemented starting with lot n0640734 (jun2014) to prevent further occurrences of excess moisture in the vials. the manufacturer advises the affected users to: discard vials exhibiting yellow/ brownish colour after reconstitution; and run quality controls at least once every 8 hours in accordance with good laboratory practice and insert sheet instructions. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con477294 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 december 2014.

Device

HemosIL PT-Fibrinogen HS PLUS
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Instrumentation Laboratory HemosIL PT-Fibrinogen HS PLUS
  • Manufacturer
    Instrumentation Laboratory

Manufacturer

Instrumentation Laboratory