Events

Alerte De Sécurité sur NeoBase Non-Derivatized Assay Solutions

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

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
    2015-03-02
  • Date de publication de l'événement
    2015-03-02
  • 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_20150302.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: perkinelmer neobase non-derivatized assay solutions medical device manufacturer, perkinelmer, has issued a medical device safety alert concerning its neobase non-derivatized assay solutions [product number: 3041-0020; lot number: 1063599401, 1063599501]. the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye. the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye. according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2015.

Device

NeoBase Non-Derivatized Assay Solutions
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: PerkinElmer NeoBase Non-Derivatized Assay Solutions
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer