Events

Alerte De Sécurité sur IRISpec CA/CB/CC and IRISpec CA/CB

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

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
    2016-04-18
  • Date de publication de l'événement
    2016-04-18
  • 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_20160418a.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: iris international irispec ca/cb/cc and irispec ca/cb medical device manufacturer, iris international, has issued a medical device safety alert concerning its irispec ca/cb/cc and irispec ca/cb. the affected products are identified as follows:- reference number: 800-7211 lot numbers: 336-15, 343-15 (exp april 2016) lot numbers: 004-16,006-16,019-16,021-16,182-15 (exp may 2016) reference number: 800-7702 lot numbers: 313-15, 336-15 (exp april 2016) lot numbers: 004-16 (exp may 2016) reference number: 800-0074 lot number: 309-15 (exp april 2016) the manufacturer has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until qc passes. there is no impact to patient results. the manufacturer is advising users to ensure the directions for handling and storage of the control material as per the instructions for use are followed to prevent premature degradation of the control material. users are advised to discard the bottle if the irispec ca control for bilirubin fails and use alternative bottles in the kit. if the problem persists, users are advised to request a product replacement from the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2016.

Device

IRISpec CA/CB/CC and IRISpec CA/CB
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Iris International IRISpec CA/CB/CC and IRISpec CA/CB
  • Manufacturer
    Iris International

Manufacturer

Iris International