Events

Rappel de Beckman Coulter LH 750 & 780 Hematology Analysers (An in vitro diagnostic device (IVD))

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01019-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-09-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01019-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    An internal investigation indicates that specific lots of check valves used in several locations within the lh 750 and lh 780 analysers may fail. this failure may result in air or liquid leak at the connection to the vacuum overflow tank waste line or at the backwash tank drain line. there is a remote risk of reporting false high or false negative results for all parameters on control and patient samples if the backwash tank fails to refill after manual aspiration. there is also a risk for a leak of biohazardous waste if the check valve fails at the vacuum overflow tank waste line. this risk is limited to samples analysed using the manual aspiration mode.
  • Action
    Beckman Coulter is recommending users review manual mode sample results if the "Backwash Tank Not Full" error occurs for all samples obtained since the last acceptable QC run. Beckman Coulter is advising users to avoid physical contact with a possible leak and follow personal protective equipment (PPE) guidelines as recommended in the Instructions for Use (IFU). Beckman Coulter will be contacting all sites to arrange an on-site visit to inspect valves and replace any affected valves.

Device

Beckman Coulter LH 750 & 780 Hematology Analysers (An in vitro diagnostic device (IVD))
  • Modèle / numéro de série
    Beckman Coulter LH 750 & 780 Hematology Analysers (An in vitro diagnostic device (IVD))Beckman Coulter LH 750 Hematology AnalyserProduct Numbers: 6605632 & A85570Beckman Coulter LH 780 Hematology AnalyserProduct Numbers: 723585 & A90728ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd