Events

Alerte De Sécurité sur BRAHMS Neopterin EIA

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

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
    2015-10-22
  • Date de publication de l'événement
    2015-10-22
  • 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_20151022b.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: thermo fisher scientific brahms neopterin eia medical device manufacturer, thermo fisher scientific, has issued a field safety notice regarding the brahms neopterin eia. the details of the affected device are shown below: kit reference number: 99.1 lot number (expiry date): 703449 (16 october 2015) and 703450 (8 january 2016) the manufacturer informs that for the brahms neopterin eia lot 703449 and lot 703450 the“quality control report”, which is included in the kit, contains an incorrect range for the quality control k2. this might lead to validating a run, which in fact was invalid. the manufacturer advises affected users to take the following actions:- stop using the incorrect quality control range for k2 contained in brahms neopterin eia, lot 703449 and lot 703450 use the correct quality control range for k2 contained in brahms neopterin eia, lot 703449 and lot 703450 provided by the manufacturer. re-evaluate all runs, which showed a value for quality control k2 between 44.4 nmol/l and 60.4 nmol/l. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 october 2015.

Device

BRAHMS Neopterin EIA
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Thermo Fisher Scientific BRAHMS Neopterin EIA
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific