Events

Alerte De Sécurité sur Clongene Biotech CLUNGENE hCG Pregnancy Test

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

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
    2014-09-30
  • Date de publication de l'événement
    2014-09-30
  • 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_20140930b.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: hangzhou clongene biotech clungene hcg pregnancy test the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning clungene hcg pregnancy test, manufactured by hangzhou clongene biotech co., ltd. with the following details: lot no.: 13122001 and 14060301 types: strip, cassette and midstream the clungene hcg pregnancy test midstream (lot 13122001 and 14060301) gave 17 false positive results at 5 ireland healthcare facilities from 12th june 2014 to 7th august 2014. the manufacturer tested the reserved samples of lot13122001, lot14060301 in the factory and returned 20pcs sticks from distributor, and all test results are passed. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 30 sep 2014.

Device

Clongene Biotech CLUNGENE hCG Pregnancy Test
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hangzhou Clongene Biotech CLUNGENE hCG Pregnancy Test
  • Manufacturer
    Hangzhou Clongene Biotech Co.

Manufacturer

Hangzhou Clongene Biotech Co.