Events

Alerte De Sécurité sur vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3

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
    2014-03-28
  • Date de publication de l'événement
    2014-03-28
  • 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_20140328a.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 chemistry products specialty diluent and vitros chemistry products fs diluent pack 3 medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros chemistry products specialty diluent lot f3168 (product code 8559825) & vitros chemistry products fs diluent pack 3 lot 01-3266 (product code 6801754). the manufacturer confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. when using the affected lots of diluent, results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor. the manufacturer advises affected users to take the following actions:- immediately discontinue using and discard all remaining inventory of vitros specialty diluent, lot f3168 and/or vitros fs diluent pack 3, lot 01-3266. review previously reported results using the affected lots. discuss any concerns regarding previously reported results with their laboratory medical director or with the requesting physician. 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 28 mar 2014.

Device

vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics