Events

Retiro De Equipo (Recall) de HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT DM analysers). 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 Radiometer Pacific Pty Ltd.

¿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
    Recall
  • ID del evento
    RC-2016-RN-00237-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-09
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00237-1
  • 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
    Hemocue has recently become aware of a production related problem that affects hemocue glucose 201rt microcuvettes. during an internal investigation a minor deviation was found, which may cause the microcuvettes to not perform as intended. there was an incorrect position for the sleigh in the final punch which affects the grouping of cuvettes with respect to measuring level. the accuracy of glucose levels below 4.1mmol/l may deviate by up to +0.9 mmol/l, resulting in falsely high results. there is also a low possibility that results in the range of 6.6-8.8 mmol/l may be falsely elevated.No harm to patients has been reported. however, there is a risk that a false high result for low glucose levels could lead to delayed or missed diagnosis of hypoglycaemia, as clinical symptoms are not always present.
  • Acción
    Radiometer is advising users that the affected product can continue to be used in adults. The affected lots should not be used in neonates or infants. Users should verify low or marginal results via another method.

Device

HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT...
  • Modelo / Serial
    HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT DM analysers). An in vitro diagnostic medical device (IVD)Product Code: 114701Batch Numbers: 1506998, 1507909, 1508920, 1405990, 1407901, 1410921, 1411931, 1501939, 1501950, 1504972, 1506995 ARTG Number: 222660
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd