Events

Alerte De Sécurité sur vitros immunodiagnostic products nt-probnp calibrators, vitros immunodiagnostic products nt-probnp reagent packs

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

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
    2014-04-08
  • Date de publication de l'événement
    2014-04-08
  • 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_20140408.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: ortho clinical diagnostics vitros immunodiagnostic products nt-probnp calibrators, vitros immunodiagnostic products nt-probnp reagent packs medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its viitros immunodiagnostic products nt-probnp calibrators (product code 6802157; lot 1110) and vitros immunodiagnostic products nt-probnp reagent packs (product code 6802156; lot 1110). during routine internal testing, the manufacturer identified potential for non-reproducible, higher than expected results that may exceed the decision thresholds for congestive heart failure (chf) when using vitros nt-probnp reagent packs, lot 1110. when using the affected lots of products, elevated results were observed across the measuring range of the assay (5.00 to 35,000 pg/ml and 0.590 to 4130 pmol/l). analysis determined that this issue may affect approximately 1 in 73 test results, or 1.37%. the manufacturer advises affected users to take the following actions:- immediately discontinue using and discard all remaining vitros nt-probnp calibrators and reagent packs, lot 1110. review previously reported results using vitros nt-probnp reagent packs, lot 1110. according to the manufacturer, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 april 2014.

Device

vitros immunodiagnostic products nt-probnp calibrators, vitros immunodiagnostic products nt-probn...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Immunodiagnostic Products NT-proBNP Calibrators, VITROS Immunodiagnostic Products NT-proBNP Reagent Packs
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics