Events

Alerta De Seguridad para LifeScan OneTouch SureStep blood glucose test strips with incorrect readings

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Johnson & Johnson.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2010-02-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20100217.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Press release
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Press release: Recall of LifeScan OneTouch SureStep blood glucose test strips with incorrect readings
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson