Events

Retiro De Equipo (Recall) de Chemistry 1 Calibrator (used with the 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-01243-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-22
  • 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-01243-1
  • 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 affected lots may produce depressed results with current lots of calcium reagent. although the affected lots are expired, the calcium calibration interval is 90 days; therefore, it is possible that calibrations using the affected calibrator lots are active. average bias for current calcium (ca) reagent lots ranges from -0.08 mmol/l to -0.2 mmol/l with a maximum individual sample bias of -0.3 mmol/l. biases were calculated based on the differences observed when comparing to results generated using nist standard material for calibration. biases were similar for urine and serum samples and were not dependent upon calcium concentration. when this issue occurs, the potential exists for misinterpretation of calcium levels, which may affect consideration of intervention.
  • Acción
    Siemens is advising user that if they have an active calibration of Calcium (CA) that used calibrator lot 5GM081 or 5GM082, recalibrate CA with an alternate lot of CHEM 1 CAL. Siemens is not recommending a review of previously generated results.

Device

Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical dev...
  • Modelo / Serial
    Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical device (IVD)Catalogue Numbers: KC110, KC110BSiemens Material Numbers: 10445169, 10716281Lot Numbers: 5GM081, 5GM082Expiry: 1 July 2016ARTG Number: 182222
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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