Events

Alerte De Sécurité sur One Step 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 Blue Cross Bio-Medical.

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
    2016-01-14
  • 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_20160114b.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
    Press release
  • Cause
    Press release: recall of two batches of one step hcg pregnancy test the department of health (dh) today (january 14) drew public attention to the recall by the therapeutic goods administration (tga) of australia concerning the one step human chorionic gonadotropin (hcg) pregnancy test (batch numbers: 20150314 and 20140406) manufactured by blue cross bio-medical (beijing) co ltd, as they may give false negative results. the dh, through its routine surveillance on medical devices, noticed a recall notice issued by the tga of australia. according to the alert, there were complaints lodged by the users about false negative results of the product. results of subsequent testing undertaken by the tga have shown that these two batches do not comply with the claim in the instructions for use, which specify that "in less than 5 minutes, levels of hcg as low as 25miu/ml can be detected." batch 20150314 has failed to detect hcg in human urine at concentrations of 10, 25 and 50miu/ml levels while batch 20140406 has failed at hcg concentrations of 10, 25, 50 and 100miu/ml. a spokesman for the dh explained that false negative results in the worst case can result in misdiagnosis and significant harm. "although preliminary enquiry with the manufacturer reveals no evidence of the affected product having been distributed in hong kong, a public alert is justified as there may be patients in the territory who have obtained the product from abroad or from internet purchase. the public is advised to stop using the concerned batches of the product and seek the advice of healthcare professionals if in doubt," the spokesman said. so far, the dh has not received any local report of adverse incidents arising from use of the product. ends/thursday, january 14, 2016issued at hkt 19:57.

Device

One Step HCG Pregnancy Test
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of two batches of One Step HCG Pregnancy Test
  • Manufacturer
    Blue Cross Bio-Medical

Manufacturer

Blue Cross Bio-Medical