Events

Retiro De Equipo (Recall) de ARCHITECT SYSTEM - HEMOGLOBIN A1C REAGENT KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION.

¿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
    53321
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-12-21
  • 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
    It was identified that interference from fetal hemoglobin (hbf) occurs at a level lower than what is stated in the architect hemoglobin alc (ln 4p52-21) package insert. the package insert indicates that the hemoglobin alc (hbalc) assay is susceptible to interference effects from hbf at> 20yo while the most current data shows interference at hbf at >5%. all in-date lots of ln 4p52-21reagent inventory are impacted.

Device

ARCHITECT SYSTEM - HEMOGLOBIN A1C REAGENT KIT
  • Modelo / Serial
    Model Catalog: 4P52-21 (Lot serial: 50279UQ12); Model Catalog: 4P52-21 (Lot serial: 50031UQ10); Model Catalog: 4P52-21 (Lot serial: 50030UQ10); Model Catalog: 4P52-21 (Lot serial: 50616UQ02); Model Catalog: 4P52-21 (Lot serial: 50615UQ02); Model Catalog: 4P52-21 (Lot serial: 50614UQ02); Model Catalog: 4P52-21 (Lot serial: 50613UQ02); Model Catalog: 4P52-21 (Lot serial: 50282UQ12); Model Catalog: 4P52-21 (Lot serial: 50007UQ10); Model Catalog: 4P52-21 (Lot serial: 51457UQ08); Model Catalog: 4P52-21 (Lot serial: 51177UQ06); Model Catalog: 4P52-21 (Lot serial: 50884UQ04); Model Catalog: 4P52-21 (Lot serial: 50281UQ12); Model Catalog: 4P52-21 (Lot serial: 50280UQ12)
  • Descripción del producto
    ARCHITECT Hemoglobin A1c
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC