Events

Alerte De Sécurité sur Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card

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

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
    2014-07-28
  • Date de publication de l'événement
    2014-07-28
  • 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_20140728.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: ortho clinical diagnostics blood grouping reagent mts a/b/d monoclonal and reverse grouping card medical device safety alert: ortho clinical diagnostics blood grouping reagent mts a/b/d monoclonal and reverse grouping card the manufacturer observed an increased number of complaints related to false positive and/or reactions containing haze in the anti-a and buffered gel micro-tubes used for reverse abo typing in the mts a/b/d monoclonal and reverse grouping card lots listed above. investigation by the manufacturer determined that the false positive reactions were due to broken gel beads in the micro-tubes of the mts cards. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/40629r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 july 2014.

Device

Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ortho Clinical Diagnostics Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics