Events

Retiro De Equipo (Recall) de Siemens Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿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
    18533
  • Fecha de inicio del evento
    2018-07-10
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Siemens healthcare diagnostics has confirmed that a number of lots can lead to the failure of calibration on sysmex® ca-1500, ca-7000, cs-2000i, cs-2100i, and cs-5100 instruments., in case the berichrom protein c calibration curve on the above mentioned systems is indicated as being invalid due to the 0% point of the calibration by "reaction curve error", the measurement signal does not meet the instrument's check algorithm for at least a value of 0.001dod and therefore this point gets flagged., follow-up communication, the manufacturer has issued a new protocol disc version with new and enhanced assay applications for sysmex cs-2000i/cs-2100i systems. this also includes a new protocol disc version with new and enhanced assay applications for sysmex cs-2500 systems and on sysmex cs-5100 systems.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments
  • Modelo / Serial
    Model: Catalogue Numbers: OUVV15 & OUVV17, Affected: First affected lot: 45059 (subsequent lots with higher lot numbers might also be affected), plus 44851
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479