Events

Alerte De Sécurité sur VIDAS FSH

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

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
    2018-03-09
  • Date de publication de l'événement
    2018-03-09
  • 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_20180309.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: biomérieux, vidas fsh medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas fsh. the affected products are identified as below: product references: a) 30407; b) 30407-01. lot numbers: a) 1005888220, 1006006370, 1006080890, 1006094700 and 1006214640; b) 1005888210. the manufacturer has received several complaints for invalid calibration with low calibrator s1 while using vidas fsh reference 30407 / 30407-01. tests performed in-house confirmed a decrease of the strips signal overtime for the impacted lots. according to the manufacturer, the defect was highlighted with complaints for invalid calibration, but concerns all testing performed (calibration and patient’s samples testing). the investigation concluded that this could have an impact on patient results. there are two possible situations as following: in case of invalid calibration: an error message appears and it will not be possible to perform further testing with the concerned lot. in this context, the risk for patients is a delayed result due to invalid calibration. in case of valid calibration: false results (falsely overestimated or falsely underestimated results) may happen. affected users are requested to destroy the impacted lots. for tests previously performed using the impacted lots of vidas fsh, the affected users are asked to discuss any concerns they may have regarding previously reported patient results obtained with the clinicians to determine the appropriate course of action. results should be reviewed and interpreted within the overall clinical context. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 march 2018.

Device

VIDAS FSH
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMérieux, VIDAS FSH
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux