Events

Retiro De Equipo (Recall) de SSP UNITRAY - HIGH RESOLUTION CLASS II

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LIFE TECHNOLOGIES CORPORATION.

¿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
    23933
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-04-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    One complaint regarding this issue has been received. one customer complaint (pr184220) was recorded. a customer reported that the reactivity for lanes 13 27 30 39 and 40 was negative for the dpb1*99:01 allele when the labeling of the dpb1 ssp unitray 12 tests kit (451606d) indicates the reactivity should be positive. the labeling discrepancy may lead to potentially mistyping a dpb1*99:01 allele (population frequency < 0.01%) as a dpb1*39:01 allele. after investigation it was determined that the dpb1 ssp unitray with taq 12 tests kit (451616d) and the allset gold dpb1 high res ssp kit (54070d) are also affected by the labeling issue since they contain the same primer present in the dpb1 ssp unitray 12 tests kit (451606d). life technologies confirmed the issue on 11 march 2015.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Modelo / Serial
    Model Catalog: 451606D (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 451616D (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 54070D (Lot serial: 009 1450550); Model Catalog: 54070D (Lot serial: 009 1544263); Model Catalog: 54070D (Lot serial: 009 1608835); Model Catalog: 54070D (Lot serial: 009 1377591); Model Catalog: 54070D (Lot serial: 009 1618548)
  • Descripción del producto
    DPB1 SSP UNITRAY W/TAQ 12 TEST DPB1 SSP UNITRAY 12 TESTS
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION