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
    2016-08-17
  • Date de publication de l'événement
    2016-08-17
  • 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_201608017.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: all unicel dxh 600 coulter cellular analysis system reference: b23858 software version: all maccording to the manufacturer, there is a possibility of specimen misidentification for the stand-alone dxh 800 and dxh 600 where the primary identifier is configured to tube position id. this issue does not occur if the primary identifier is configured as specimen id mresults from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs: the primary identifier is tube position id. a patient control file is setup for id xxxxx, and a pending test order for a patient sample id xxxxx is subsequently added to the worklist. the patient control sample is analyzed using cassette presentation but that tube does not contain a barcode-labeled specimen id or the label cannot be read. mupon analysis, the results from the analyzed patient control tube will be associated with the patient sample that was pending on the worklist and not the patient control file mthe manufacturer is investigating this issue in order to provide a resolution. affected users are advised to ensure that there are no pending or active patient test orders in the worklist before analyzing a patient control with a tube position id maccording to the local supplier, unicel dxh 800 coulter cellular analysis system is distributed in hong kong mif you are in possession of the affected products, please contact your supplier for necessary actions. mposted on 17 august 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