Retiro De Equipo (Recall) de Combur-Test and ChoiceLine 10 test kits (urine test strips). An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The instructions for use (ifu) contain an error regarding gram-status of bacteria for the nitrite test. in the limitations or accuracy section, gram-negative bacteria have been incorrectly referred to as gram-positive. however, the strip performance is not affected, so the product can still be used as specified. if a physician is not aware that a positive nitrite result is indicative of gram-negative bacteria, but follows the incorrect classification within the ifu, an insufficient class of antibiotic may be chosen for the initial treatment of urinary tract infection (uti). however, the “gram-classification” of bacteria should be common medical knowledge and use of recommended processes for identification of uti-causing bacteria (such as urine culture methods) will mitigate risk. nevertheless, a medical risk for patients due to an insufficient antibiotic chosen initially cannot entirely be excluded.
  • Acción
    Roche is advising users of the correct wording for the Instructions for Use (IFU). A revised IFU will be provided to users, and additional information provided with each lot of product until the IFU is corrected. This action has been closed-out on 18/05/2017.


  • Modelo / Serial
    Combur-Test and ChoiceLine 10 test kits (urine test strips). An in vitro diagnostic medical device (IVD) ChoiceLine 10 testMaterial Number: 03504379023Combur10 Test UXMaterial Number: 11544373049Combur10 TestMaterial Number: 04510089056 Combur9 TestMaterial Number: 04510054056All lots affectedARTG Number: 224003
  • Manufacturer