Events

Alerte De Sécurité sur LifeScan OneTouch SureStep blood glucose test strips with incorrect readings

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

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
    2010-02-12
  • 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/press_20100217.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
    Press release
  • Cause
    Recall of lifescan onetouch surestep blood glucose test strips with incorrect readings the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company had initiated a voluntary recall of blood glucose test strip which may provide low readings. only one affected lot (lot number 2966727) of lifescan onetouch surestep test strips was supplied to hong kong. the affected test strips may provide low test results when the blood glucose level is greater than 22.2mmol/l, a dh spokesman said. "a total of 2,160 boxes of the lot have been imported to hong kong. among them, 2,116 unsold boxes have already been retrieved from the market. only 44 boxes have been sold in hong kong," the spokesman said. the dh has not received any report of adverse events arising from the test strip. members of the public should stop using the affected product and contact the company at hotline 3128 8101. it will operate daily from 9am to 6pm including the chinese new year holidays. the department will closely monitor the recall. ends/friday, february 12, 2010.

Device

LifeScan OneTouch SureStep blood glucose test strips with incorrect readings
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of LifeScan OneTouch SureStep blood glucose test strips with incorrect readings
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson