Events

Alerte De Sécurité sur Unicel DxH Cellular Analysis Systems

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
    2015-12-07
  • Date de publication de l'événement
    2015-12-07
  • 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_20151207b.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 unicel dxh cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning unicel dxh 800, dxh slidemaker stainer (sms) and dxh 600 cellular analysis systems. the affected products are identified as follows: dxh 800: reference number: 629029, b24465, b24802; software version: 3.0.2.0 dxh sms: reference number: 775222; software version: 3.0.2.0 dxh 600: reference number: b23858; software version: 1.1.1.0 the manufacturer has determined that the software for the affected dxh systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager. the issue does not occur for edits of released results or for test orders requested through host transmission. according to the manufacturer, the issue creates the potential for sample misidentification and possibility of releasing erroneous results. the manufacturer is advising customers not to edit the specimen id for a pending test order at the system manager’s worklist – pending or worklist – review tabs. 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 7 december 2015.

Device

Unicel DxH Cellular Analysis Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Unicel DxH Cellular Analysis Systems
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter