Events

Retiro De Equipo (Recall) de ALLSET GOLD ABDRQ LOW RESOLUTION KIT

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
    31128
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-03-19
  • 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
    Abc unitray ssp kits have a false negative in lane 13. internal investigation confirmed by sequence based typing that the customer had a sample type with a a*32:04 allele. therefore lane 13 has a confirmed false negative in the affected kits. however the primer mix in lane 13 is functioning as designed. the a*32:04 allele has an undefined sequence region which had not been confirmed through testing. the worksheet is incorrect in listing this allele as positive for lane 13.

Device

ALLSET GOLD ABDRQ LOW RESOLUTION KIT
  • Modelo / Serial
    Model Catalog: 54360D (Lot serial: 028 984379); Model Catalog: 54340D (Lot serial: 037 791458); Model Catalog: 54340D (Lot serial: 037 1099919); Model Catalog: 78100-10 (Lot serial: 035 757737); Model Catalog: 78100-10 (Lot serial: 035 709363); Model Catalog: 78100-10 (Lot serial: 035 841438); Model Catalog: 78100-10 (Lot serial: 035 1091909); Model Catalog: 78000-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78601-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78600-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78001-10 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    Invitrogen AllSet Gold SSP HLA ABDRDQ Low Res Kits
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION