Events

Alerte De Sécurité sur Calibration Data Module

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
    2014-02-07
  • Date de publication de l'événement
    2014-02-07
  • 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_20140207a.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 calibration data module medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its calibration data module (cdm prom) [affected lot: 0168 catalogue number: 1999077]. a cdm prom is an electronic device that contains data required to perform various tests on the vitros dt60/dt60 ii chemistry systems. according to the manufacturer, this product correction notification has been initiated due to an inability to calibrate or use vitros crsc dt slides, gen 82 when using cdm prom 0168. calibration data module (cdm prom) 0168 contains data that allows the use of new lots of vitros dt slides and vitros dt calibrator kits on vitros dt60/dt60 ii chemistry systems. this cdm prom was sent to all customers beginning in october 2013. the manufacturer has received complaints for the inability to calibrate or subsequently use vitros crsc dt slides, gen 82 after the installation of cdm prom 0168. according to the local supplier, 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 07 february 2014.

Device

Calibration Data Module
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ortho Clinical Diagnostics Calibration Data Module
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics