Events

Alerte De Sécurité sur ID-DiaCell I-II-III Asia

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

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
    2017-09-04
  • Date de publication de l'événement
    2017-09-04
  • 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_20170904.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: bio-rad id-diacell i-ii-iii asia medical device manufacturer, bio-rad, has issued a medical device safety alert concerning its id-diacell i-ii-iii asia. the affected products are identified as follows:- product code: 45330 lot/serial numbers: ihd lot n°: 45330 29 1 (expiry date: 09.10.2017) / sap lot n°: 167516291 (expiry date: 11.09.2017) ihd lot n°: 45330 29 2 (expiry date: 23.10.2017) / sap lot n°: 168117292 (expiry date: 23.10.2017) ifu/um reference: b004350 version 02.15 the manufacturer has been made aware that unexpected positive reactions may occur with the cell iii of the product id-diacell i-ii-iii asia, ihd lot n° 45330 29 1 and 45330 29 2 according to the manufacture’s health risk assessment, there is no patient risk because by following the good laboratory practice practices the issue (false positive reaction) will be identified during internal quality control. the manufacturer requests customers to scrap any remaining goods of the ihd lots 45330 29 1 and 45330 29 2. the manufacturer is sending the lots 45330 30 1 respectively 45330 30 2 as a replacement in week 36. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 4 september 2017.

Device

ID-DiaCell I-II-III Asia
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bio-Rad ID-DiaCell I-II-III Asia
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad