Events

Alerte De Sécurité sur GLUCOSE-6 PHOSPHATE DEHYDROGENASE (G-6-PDH)

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

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
    2016-12-23
  • Date de publication de l'événement
    2016-12-23
  • 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_20161223b.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: trinity biotech glucose-6 phosphate dehydrogenase (g-6-pdh) medical device manufacturer, trinity biotech, has issued a medical device safety alert concerning its glucose-6 phosphate dehydrogenase (g-6-pdh). the details of the affected device are as follows:- assay product code: 345a lot number: f117009 (expiry date: 04-apr-18) date of manufacture: 04 apr 16 assay product code: 345b lot number: f229031 (expiry date: 18-jul-18) date of manufacture: 18 jul 16 the manufacturer has identified a potential for misdiagnosis with lots f117009 and f229031. a recent investigation has identified that these two lots display a level of accuracy variation outside the historical qc product release process control charts for normal range controls, despite falling within the qc acceptance specification. kits from these two lots must be destroyed. investigation testing has shown that there is objective evidence that the accuracy issue affects the normal patient range and not the deficient range with a potential health hazard of a false positive result (normal patient diagnosed as deficient) or an invalid test result occurring. affected users and end-users are asked to comply with the following actions with immediate effect: discontinue the use of the lots f117009 and f229031. destroy any remaining product. in line with their laboratory’s internal procedures, consider the need to review results previously generated using these lots. notify all end-users of this notification. according to the manufacturer, 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 23 december 2016.

Device

GLUCOSE-6 PHOSPHATE DEHYDROGENASE (G-6-PDH)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Trinity Biotech GLUCOSE-6 PHOSPHATE DEHYDROGENASE (G-6-PDH)
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech