Events

Alerte De Sécurité sur AU480 Chemistry Analyzer

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

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
    2015-09-29
  • Date de publication de l'événement
    2015-09-29
  • 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_20150929c.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: beckman coulter au480 chemistry analyzer medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its au480 chemistry analyzer [software version 1.81]. a software defect has been identified on newly installed au480 systems with software version 1.81. the defect may generate incorrect test results for 2 step method assays on au480 systems configured with closed channels. new au480 systems configured to allow for full open channels are not affected. the software defect occurs when edit and then confirm are pressed on the specific test parameters screen of closed channels. the result is the measuring point-2 settings will be deleted. the measuring point 2 settings are used for sample blank adjustments for 2 step methods. for samples which may have lih (lipemia, icterus, hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels. 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 29 september 2015.

Device

AU480 Chemistry Analyzer
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter AU480 Chemistry Analyzer
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter