Events

Retiro De Equipo (Recall) de CALRETININ ANTIBHODY - LIQUID MONOCLONAL

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LEICA BIOSYSTEMS NEWCASTLE LTD..

¿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
    145575
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-04
  • 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
    Leica biosystems recently became aware that novocastra liquid mouse monoclonal antibody calretinin only performed as expected with specific lots of diluents: - ar9352 (lots slbl4196v slbl8154v slbm1997v slbm3199v) - ar9352-cn (lots slbl8154v slbm1997v) - re7133-ce (lot 6035000) - re7133-cn (lot 6035115) in the event that the product is used with diluents other than those listed it may not provide adequate staining. when used according to the instructions for use with appropriate positive controls the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. in these instances the absence of adequate staining of tisse is likely to result in a delay in obtaining the results of ihc / ish staining and in a worst-case scenario could cause a delay in the diagnosis or classification of a neoplasm. this notice only applies to novocastra liquid mouse monoclonal antibody calretinin.

Device

CALRETININ ANTIBHODY - LIQUID MONOCLONAL
  • Modelo / Serial
    Model Catalog: NCL-L-CALRET-566 (Lot serial: 6029949); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6029060); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6025204); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6036060); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6035923)
  • Descripción del producto
    NOVOCASTRA LIQUID MOUSE MONOCLONAL ANTIBODY CALRETININ
  • Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.

Manufacturer

LEICA BIOSYSTEMS NEWCASTLE LTD.
  • Dirección del fabricante
    NEWCASTLE UPON TYNE
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC