Events

Alerte De Sécurité sur Calcium Gen.2 (CA2)

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
    2014-05-02
  • Date de publication de l'événement
    2014-05-02
  • 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_20140502.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 calcium gen.2 (ca2) medical device manufacturer, roche, has issued a field safety notice concerning calcium gen.2 (ca2). the affected catalogue numbers are 05061431190, 05061458190, 05061466190 and 05061474190. according to the manufacturer’s global complaint record, they received some customers complained of: duplicate and sens alarms during calibration, drop in quality control (qc) results , poor intermediate coefficient of variations (cv) for the ca2 (nm-bapta method) on the modular analytics analyzers. however, ca (gen.1) may seem to perform adequately. according to the manufacturer, it is assumed that the mentioned precision issue is due to the sensitivity of the ca2 assay to the maintenance condition of the modular analytics . on an analyzer maintained according to the manufacturer’s recommendations, the precision of ca2 should be within specifications. the manufacturer will implement a special hardware checking protocol to make sure the hardware condition of the system is satisfactory in the next preventative maintenance. furthermore, the manufacturer advises users to review their ca2 assay performance to see if they are affected by the mentioned symptoms. if users suspect that they are affected by the mentioned issue, the manufacturer advises them to perform a within run imprecision study (n=21) using qc materials for troubleshooting. the cv of the imprecision study should below 2%. then, users should contact the roche application representative with relevant data. 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 2 may 2014.

Device

Calcium Gen.2 (CA2)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Calcium Gen.2 (CA2)
  • Manufacturer
    Roche

Manufacturer

Roche