Events

Retiro De Equipo (Recall) de Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). 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 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-2016-RN-00801-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-16
  • 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-00801-1
  • 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 identified that dimension creatinine (cre2) assay exhibits a negative bias at the low end of the urine analytical measurement range (amr).The limit of quantitation (loq) claim (442 µmol/l) for urine samples is not met. this issue affects all future lots of cre2 until a solution is implemented. the serum/plasma cre2 amr is not affected by this issue.The bias observed for urine creatinine samples < 1149 ìmol/l would not impact clinical interpretation of adult egfr calculations or clinical interpretation of laboratory tests utilizing creatinine as a correction factor, such as urine albumin/creatinine ratio and/or urine protein/creatinine ratio.
  • Acción
    Siemens is advising users to review the maximum observed bias for low urine concentrations. It is recommended that urine CRE2 values that are less than 1149umol/L are reported as <1149umol/L rather than an actual numeric result. Siemens is providing work around instructions for users to change the lower assay range parameters to 1149umol/L. Siemens is not recommending a review of previously generated results.

Device

Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). An i...
  • Modelo / Serial
    Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). An in vitro diagnostic medical device (IVD)Catalogue Number: K1033ASiemens Material Number: 10872082All lot numbers affectedARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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