Events

Alerte De Sécurité sur Lyra MP Reader II

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

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
    2015-07-23
  • Date de publication de l'événement
    2015-07-23
  • 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_20150723_2.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: diamed lyra mp reader ii it has come to our attention that medical device manufacturer, diamed, has issued a field safety notice concerning an automated blood grouping system - lyra mp reader ii [model number: 854002]. the manufacturer became aware that, in exceptional circumstances, the blood grouping system may incorrectly assign the results of the previously read microplate to the microplate being processed. in this specific context, the misallocated results are displayed in black and white instead of colour as would be expected. this issue could in the worst case lead to a mismatch between the test result issued and the true result of the sample. according to the manufacturer, the potential for reporting an erroneous result is very limited because the occurrence of the issue is dependent on several exceptional random factors operating together. the manufacturer advised users to use an empty microplate for balance purpose and deactivate the automatic validation of results for the system. the users should also check the colour of the results displayed before validation and should not validate the results if the images of wells appeared in black and white. as a permanent solution, the manufacturer will release a software update. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 july 2015.

Device

Lyra MP Reader II
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DiaMed Lyra MP Reader II
  • Manufacturer
    DiaMed

Manufacturer

DiaMed