Events

Alerte De Sécurité sur UREA/BUN for Modular system

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

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
    2015-04-09
  • Date de publication de l'événement
    2015-04-09
  • 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_20150408.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: roche urea/bun for modular system medical device manufacturer, roche, has issued a medical device safety alert concerning its urea/ blood urea nitrogen (urea/bun) for modular system. the affected reference numbers are 11729691216, 11929470216, 11929488216, 11929496216, 11929500216 and 11489364216. according to the manufacturer, rounding error occurred during calculation of measuring ranges and technical limits in different units. the error leads wrong measuring ranges and technical limits being stated in the instruction of use and setting in the analyzers. thus, these values have to be corrected as well as harmonized in case where the values stated in the parking insert and setting is not coherent the manufacturer has corrected the measuring range and technical limit for urea/urea nitrogen assay and harmonized in the packing insert as well as in the settings for serum and urine for modular analytics p and d. according to the local supplier, 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 9 april 2015.

Device

UREA/BUN for Modular system
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche UREA/BUN for Modular system
  • Manufacturer
    Roche

Manufacturer

Roche