Events

Alerte De Sécurité sur Automated Haematology Analyser

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

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
    2013-10-16
  • Date de publication de l'événement
    2013-10-16
  • 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_20131016e.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: sysmex automated haematology analyser the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) has posted a field safety notice concerning automated haematology analyser [model no: xn-10 & xn-20; serial no.: all], manufactured by sysmex corporation. the manufacturer was informed from the uk market that in very rare cases falsely high haemoglobin (hb) values may occur, creating the potential risk of missed transfusions for patients with low hb values. as this does not occur in samples which were mixed correctly, the manufacturer deduces that correct pre-analytical procedures and mixing can prevent this phenomenon. in studies performed on the xn-series analysers, the manufacturer has confirmed that the mixing function is effective for healthy volunteer samples which are measured less than 4 hours after the blood has been collected. however, for other samples with high viscosity or erythrocyte sedimentation rates (e.G. polymyalgia rheumatica, temporal arteritis or malignant lymphoma) or samples stored in the refrigerator, there is the possibility that the instruments standard mixing cycle may not be sufficient to suitably mix the sample. affected users are reminded to always ensure that samples are mixed sufficiently before being placed on the analyser, especially for samples from patients prone to high degrees of sedimentation or for cooled samples. according to the local supplier, the affected products were distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

Automated Haematology Analyser
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sysmex Automated Haematology Analyser
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation