Events

Alerta De Seguridad para Total SteriChek Chloroform Reagent Tapes (SteriChek Total Chlorine Reagent Strips

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Environmental Test Systems Inc.

¿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
  • ID del evento
    238
  • Fecha
    2000-12-22
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The above mentioned sterichek total chloroform reagent tapes, whose function is to measure very low levels of chloroform in drinking water for dialysis, are ineffective when used improperly for the measurement of high levels of chloroform. the manufacturer initiated a voluntary mail-order recall dated june 30, 2000. environmental test systems states that this removal does not affect any other sterichek product, including other sterichek chloroform reagent tapes.
  • Acción
    Make sure that you have received the correspondence dated June 30, 2000 from Environmental Test Systems. Identify and isolate any affected product from your inventory. SteriChek users must return all SteriChek Total Chloroform Reagent Tapes to Environmental Test Systems, to: SteriChek Customer Service by mail at the above address. Fill in the lower field of the notification letter and return it to Environmental Test Systems by fax 1 (219) 264-4533 or by mail at the above address. SteriChek distributors must provide Environmental Test Systems with a list of all consumers who have purchased the SteriChek Total Chloroform Reagent Tapes so that the manufacturer can contact them directly and make the credit arrangements through you as distributors. For free return of the product or to inform you that you do not have the affected product contact your local representative or directly with Kelli Katona, Environmental Test Systems at 1 (219) 262-2060 in the United States. For more information, contact your local representative or directly with Environmental Test Systems at 1 (219) 262-2060

Device

Total SteriChek Chloroform Reagent Tapes (SteriChek Total Chlorine Reagent Strips

Manufacturer

Environmental Test Systems Inc
  • Source
    ANVSANVISA