Events

Alerte De Sécurité sur SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip

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

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
    2016-01-29
  • Date de publication de l'événement
    2016-01-29
  • 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_20160129b.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: arkray factory inc spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip the united states food and drug administration (fda) has issued an alert concerning the spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip [lot numbers: pn5c26 and ea4m78; manufacturing dates: november 2014 to september 2015; distribution dates: 18 february 2015 to 13 october 2015], manufactured by arkray factory inc. according to the fda, the manufacturer is recalling the spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip because they may report falsely low blood glucose levels when the true levels are above 265 mg/dl. there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in a timely manner and fail to treat elevated blood glucose levels. the issue may cause serious injury or death. the manufacturer sent an urgent medical device recall letter to customers in the united states beginning on 18 december 2015. the letter identified affected product, stated the reason for recall and provided instructions for returning unused product to the firm. tfor details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=72867&w=01202016%e2%8c%a9=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm483792.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm483760.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 january 2016.

Device

SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip

Manufacturer

Arkray Factory Inc