Events

Alerte De Sécurité sur UniCel DxH 800 and UniCel DxH 600 Coulter 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
    2016-05-09
  • Date de publication de l'événement
    2016-05-09
  • 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_20160509.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 800 and unicel dxh 600 coulter cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems. the affected products are identified as follows: unicel dxh 800 coulter cellular analysis system reference.: 629029, b24465, b24802, b68304 software version: 2.0.0.0 and greater unicel dxh 600 coulter cellular analysis system reference: b23858 software version: 1.0.0.0 and greater the manufacturer has identified an issue where the rbc aperture baths can contain residue in the sweep flow fittings. this residue may potentially create increased background failures, flagged results and vote outs for rbc and plt parameters. affected users are instructed to: address any daily checks system alarms and background failures as indicated in the online help or instructions for use (part number b26647ac and b16421ad); and monitor flags on patient and control results according to their laboratory protocols. according to the local supplier, unicel dxh 800 coulter cellular analysis system is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 may 2016.

Device

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter