Events

Alerte De Sécurité sur cobas c pack carb3

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

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
    2014-03-20
  • Date de publication de l'événement
    2014-03-20
  • 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_20140320.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: roche cobas c pack carb3 medical device manufacturer, roche, has issued a field safety notice concerning cobas c pack carb3. the affected catalogue number is 04874625190 and the affected lot numbers are 676413, 689905 and 692916. on 30 april 2012, the manufacturer announced the initial cassette volume check (icvc) has been activated on the reagent barcode labels of all roche manufactured reagents which require manual filling in order to prevent erroneous results caused by incorrect filling of reagent. carb3 (cat: 04874625 190) is one of these reagents. however, the recent internal data showed that the icvc is not performed on cobas c 502 for any lot so far. due to an in-house labeling software limitation, the icvc “on” trigger are not correctly encoded in the rec files released to the market so far, and in consequence no icvc was performed on cobas c 502 for tests requiring manual reagent handling. the manufacturer has released the updated rec files which include correct icvc “on“ trigger for the affected reagent lots and will implement the icvc “on” setting in the corresponding rec file for all upcoming reagent lots. the manufacturer advises users to update the cobas link which is connected to cobas 8000 with the c502 e-library update cd. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 march 2014.

Device

cobas c pack carb3
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche cobas c pack CARB3
  • Manufacturer
    Roche

Manufacturer

Roche