Events

Alerte De Sécurité sur Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)

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

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
    2017-07-11
  • Date de publication de l'événement
    2017-07-11
  • 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_20170711b.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: horiba abx sas yumizen h500 ct (closed tube) (version 2.1.0 or lower) the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning yumizen h500 ct (closed tube) (version 2.1.0 or lower), manufactured by horiba abx sas. product development activities by the manufacturer have shown that a defective positioning of the sampling needle could, in some instances, lead to a wear of the rinsing header ring of the needle. this technical issue could generate an over estimation of platelet counting. this background is usually detected when a blank cycle is performed at instrument start up (failed start up alarm). however, in other cases, the blank cycle does not detect the potential abnormal platelet background and could generate erroneous value of platelet counting. the potential overestimation of the platelet counting value could be critical for patients with thrombocytopenia and notably with severe thrombocytopenia which could then not be detected as severe. a corrective action has been identified by the manufacturer which consists of: new sampling needle adjustment needle ring replacement the manufacturer’s technician will implement the corrective action on affected yumizen h500 ct analyzer. while waiting for the corrective action, the manufacturer recommends the following solution for the patient samples with low platelet value suspicion: perform a blank cycle if blank cycle failed, re-run blank cycle if blank cycle passed, re-run their patient sample compare the 2 sample run values and repeat the procedure in case of significant discrepancy. for details, please refer to the mhra’s website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-3-to-7-july-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 july 2017.

Device

Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HORIBA ABX SAS Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)
  • Manufacturer
    HORIBA ABX SAS

Manufacturer

HORIBA ABX SAS