Events

Alerte De Sécurité sur Access Free T3 Reagent Kit

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

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
    2016-06-16
  • Date de publication de l'événement
    2016-06-16
  • 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_20160616.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: beckman coulter access free t3 reagent kit medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its access free t3 reagent kit [reference number: a13422] for use with the access family of immunoassay systems. the manufacturer has determined through customer feedback and internal testing that the affected lots of access free t3 reagent demonstrate an upward shift in patient results. the preliminary results indicate this upward shift may be related to a june 2015 formulation design change that was introduced to improve the access free t3 open reagent pack stability. the upward shift in patient test results, therefore, is expected to be maintained for all future lots. according to the manufacturer, patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change. additional assay performance characteristics are not affected. due to matrix differences, qc values may not demonstrate a shift. customers are advised to take the following actions: discontinue using the affected access free t3 lots until their laboratory verifies that their current access free t3 reference interval(s) is appropriate; or adjusts or establishes new reference interval(s); to verify, adjust or establish new access free t3 reference interval(s); resume using the affected access free t3 lots and all future lots once their laboratory has completed the reference interval evaluation; and at the discretion of their laboratory director, notify clinicians that it is possible the access free t3 sample results previously reported by their laboratory were affected by this issue. 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 16 june 2016.

Device

Access Free T3 Reagent Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Access Free T3 Reagent Kit
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter