Events

Alerte De Sécurité sur Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents

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
    2017-04-24
  • Date de publication de l'événement
    2017-04-24
  • 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_20170424a.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 synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents [reference numbers: 467825 (chol), a60298 (cr-e), a15625 (hdl), a95550 (lact), 445850 (tg and tg-b), 442785 (uric), 378194 (saly); lot numbers: all]. the manufacturer has identified the drugs metamizole (dipyrone), sulfasalazine and sulfapyridine as potential sources of interference when using synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents. with the administration of these drugs, the effects to patient analytes are: metamizole (dipyrone) – may generate false low cholesterol, enzymatic creatinine, hdl cholesterol, lactate, triglycerides and uric acid results. sulfasalazine – may generate false high salicylate results. sulfapyridine – may generate false low salicylate results. information regarding interference with these drugs will be added to the chemistry information sheets (cis) for the respective products. the cis will be updated on the beckman coulter website's technical documents webpage. 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 24 april 2017.

Device

Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and S...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter