Events

Alerte De Sécurité sur Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor

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
    2017-05-15
  • Date de publication de l'événement
    2017-05-15
  • 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_20170515a.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 total t3, access thyroglobulin, access free t4, access gi monitor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its access total t3, access thyroglobulin, access free t4, access gi monitor [reference numbers: 3380 (total t3), 33860 (thyroglobulin), 33880 (free t4), 387687 (gi monitor); lot numbers: all] for use with the access family of immunoassay systems. the manufacturer has determined through customer feedback and internal investigation that the four access immunoassays listed above are susceptible to biotin interference. during interference testing the interference occurred with samples that contained 100 ng/ml of biotin. this level of biotin is greater than the maximum biotin concentration observed in the normal healthy population. according to the manufacturer, specimens from patients who are undergoing biotin therapy and/or ingesting biotin supplements may contain high levels of biotin. the higher biotin concentration in these specimens interferes with the biotin-streptavidin assay design of the four access assays listed previously. other access assays with a biotin-streptavidin assay design were also tested. these assays are not affected by higher biotin concentrations. specimens that contain high levels of biotin may cause: false low results for the access gi monitor and thyroglobulin assays. false high results for the access free t4 and total t3 assays. the customers are advised to take following actions: interpret results in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. a retrospective review of results is not recommended. the manufacturer will update the limitations section of the access total t3, thyroglobulin, free t4, and gi monitor instructions for use with this biotin interference information. 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 15 may 2017.

Device

Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter