Events

Retiro De Equipo (Recall) de ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY

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

¿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
    19761
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-02-06
  • 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
    Siemens healthcare diagnostics has determined through an internal investigation that the assays listed do not align with the representative data published in the instructions for use (ifu) for onboard stability calibration frequency and/or interference. the assays that did not meet the obs and the calibration frequency ifu claims are: microalbumin_2 (ualb_2) alanine aminotransferase (altp5p) lithium (lith) alkaline phosphatase (alpamp) alkaline phosphatase (alpdea) magnesium (mg) magnesium concentrated (mg_c) total protein ii (tp) acetaminophen (acet) immunoglobulin g_2 (igg_2) transferrin (trf) total bilirubin (added to customer notification due to typographical error). the assays that did not meet the interference ifu claims are: alanine aminotransferase (alt) ammonia (amm) carbon dioxide liquid (co2_l) gamma-glutamyl transferase (ggt) high sensitivity c-reactive protein (hscrp) inorganic phosphorus (ip) inorganic phosphorus_concentrated (ip_c) lactate (lac) uric acid_concentrated (ua_c) wide range crp (wrcrp) lithium (lith) alkaline phosphatase (alpamp).

Device

ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Modelo / Serial
    Model Catalog: 00141230 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02189346 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03039070 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07371282 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03036926 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02193432 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03056927 (Lot serial: > 10 numbers contact mfg); Model Catalog: 04993452 (Lot serial: > 10 numbers contact mfg); Model Catalog: 01803350 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03051194 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02271328 (Lot serial: > 10 numbers contact mfg); Model Catalog: 06837459 (Lot serial: > 10 numbers contact mfg); Model Catalog: (Lot serial: > 10 numbers contact mfg); Model Catalog: 07989138 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03035814 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07498649 (Lot serial: > 10 numbers contact mfg); Model C
  • Descripción del producto
    ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC