Events

Alerte De Sécurité sur vitros 25-oh vitamin d total calibrators

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
    2014-01-29
  • Date de publication de l'événement
    2014-01-29
  • 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_20140129.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 25-oh vitamin d total calibrators medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros 25-oh vitamin d total calibrators [product code: 6842893; lot numbers: 0091 through 0235]. the manufacturer has found that the vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235, used with vitros immunodiagnostic products 25-oh vitamin d total reagent packs, may generate negatively biased results the manufacturer advises all affected users to immediately discard all current lots of vitros immunodiagnostic product 25-oh vitamin d total calibrators and reagent packs (lots 0200, 0210, 0220, 0230 and 0235). affected users are also instructed to review previously reported results generated using vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 january 2014.

Device

vitros 25-oh vitamin d total calibrators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS 25-OH Vitamin D Total Calibrators
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics