Events

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

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
    24499
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-03-24
  • 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 (pr182500) was recorded. a customer reported a discrepant test result between ssp rssop and secore test methods. the secore and rssop test result of the dna sample was an a*30:16 a*33:03 heterozygous typing but the ssp test result allset gold a high res ssp (54010d) lot 012 1544269 was a*30:01 a*33:03 heterozygous typing based on product labeling. the labeling discrepancy may lead to potentially mistyping an a*30:16 allele (population frequency < 0.01%) as an a*30:01. also the a high res ssp unitray 10tests (4729010) a high res ssp unitray w/taq10 (4729110) a-02 ssp unitray 12 tests (470204d) and allset gold a*02 high res ssp (54110d) are affected by the labeling issue since they contain the same primer present in the allset gold a high res ssp kit. in addition to the a*30:16 allele that may be mistyped as an a*30:01 allele the investigation showed that the labeling for the reactivity of the following two alleles should be changed from positive to negative: a*03:09 (population frequency of <0.01%) a*11:06 (population frequency of 0.01%) no complaints have been received on these two alleles but updating the reactivity based on the current information may prevent future complaints on them. life technologies confirmed the issue on 19 february 2015.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Modelo / Serial
    Model Catalog: 47291-10 (Lot serial: 012 1608873); Model Catalog: 47290-10 (Lot serial: 012 1608873); Model Catalog: 470204D (Lot serial: 014 1357609); Model Catalog: 470214D (Lot serial: 014 1357609); Model Catalog: 47290-10 (Lot serial: 014 1357609); Model Catalog: 47291-10 (Lot serial: 014 1357609); Model Catalog: 470204D (Lot serial: 014 1464118); Model Catalog: 470214D (Lot serial: 014 1464118); Model Catalog: 47290-10 (Lot serial: 014 1464118); Model Catalog: 47291-10 (Lot serial: 014 1464118); Model Catalog: 470204D (Lot serial: 014 1589657); Model Catalog: 470214D (Lot serial: 012 1608873); Model Catalog: 470204D (Lot serial: 012 1608873); Model Catalog: 47291-10 (Lot serial: 012 1580702); Model Catalog: 47290-10 (Lot serial: 012 1580702); Model Catalog: 470214D (Lot serial: 012 1580702); Model Catalog: 470204D (Lot serial: 012 1580702); Model Catalog: 47291-10 (Lot serial: 012 1467113); Model Catalog: 47290-10 (Lot serial: 012 1467113); Model Catalog: 470214D (Lot serial: 012 1467113); Model Catalog
  • Descripción del producto
    A HIGH RES SSP UNITRAY 10TESTS A-02 SSP UNITRAY 12 TESTS
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION