Events

Retiro De Equipo (Recall) de SSP UNITRAY - LOW 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
    24968
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-10-21
  • 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
    During an internal complaint investigation for problem report pr#135598 the reactivity assignment in our human oligotyping software (hos) program for a32:04 allele in primer mix pm019e was determined to be incorrect. the catalog and lot numbers of the products listd above have been identified to be affected by the incorrect reactivity assignment. the kits would produce an incorrect low resolution typing or mistyping result of a*02 a*03 alleles when testing a sample which has the a32:04 allele. the user would be unaware of the incorrect type unless they confirm the sample typing by another method therefore this would be considered a mistype.

Device

SSP UNITRAY - LOW RESOLUTION CLASS I
  • Modelo / Serial
    Model Catalog: 78600-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78000-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78601-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78001-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 54340D (Lot serial: 038 1391657); Model Catalog: 54340D (Lot serial: 038 1360419); Model Catalog: 54340D (Lot serial: 038 1306788); Model Catalog: 54340D (Lot serial: 038 1249868); Model Catalog: 54310D (Lot serial: 022 1385981); Model Catalog: 54310D (Lot serial: 022 1256853); Model Catalog: 54360D (Lot serial: 029 1395129); Model Catalog: 54360D (Lot serial: 029 1247232); Model Catalog: 54360D (Lot serial: 029 1293558); Model Catalog: 54360D (Lot serial: 029 1306794); Model Catalog: 54360D (Lot serial: 029 1362561)
  • Descripción del producto
    SSP UNITARY - LOW RESOLUTION CLASS I
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION