Events

Retiro De Equipo (Recall) de Dimension Creatinine and Dimension Vista Creatinine Assays

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2015-RN-00680-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-28
  • 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-2015-RN-00680-1
  • 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
    Siemens healthcare diagnostics has determined that dimension creatinine (crea) may produce depressed results up to 12.7% (or approximately 18 µmol/l) for a creatinine result at 133 µmol/l when haemolysis exceeds 300 mg/dl [0.19 mmol/l] of haemoglobin. dimension vista creatinine (crea) may produce depressed results up to 22% (or approximately 27 ìmol/l) for a creatinine result at 133 ìmol/l when haemolysis exceeds 200 mg/dl [0.12 mmol/l] of haemoglobin.Depressed creatinine results due to haemolysis would not be expected to significantly impact medical decisions when using this assay. the potential for injury is remote due to continued monitoring, additional diagnostic testing and correlation to patient history and presentation.
  • Acción
    A workaround is provided in the form of revised interference information via the Customer Letter.

Device

Dimension Creatinine and Dimension Vista Creatinine Assays
  • Modelo / Serial
    Dimension Creatinine and Dimension Vista Creatinine AssaysDimension CREA AssayCatalogue Number: DF33A Siemens Material Number (SMN): 10444968Dimension Vista CREA AssayCatalogue Number: K1033 Siemens Material Number (SMN): 10445161All in-date and future lots are affectedARTG number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA