Events

Retiro De Equipo (Recall) de Device Recall MyAllergyTest, Specimen Collection Kit

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Immunetech Inc.

¿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
    60355
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0287-2012
  • Fecha de inicio del evento
    2011-11-04
  • Fecha de publicación del evento
    2011-11-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105092
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Causa
    Immunetech is recalling certain specimen collection kits that contain triad brand non-sterile alcohol prep pads which have been recalled by triad group, hartland, wi due to bacillus cereus, microbial contamination.
  • Acción
    The firm, IMMUNETECH, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated November 4, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory and quarantine all affected kits; if they have further distributed the affected kits, contact Immunetech to accurately identify and immediately notify their customers and facilitate the return and exchange of all remaining kits. If you have any questions, call (650) 312-1066, Monday-Friday, 9:00am -5:00pm (pacific) or email: customersupport@immunetech.com.

Device

Device Recall MyAllergyTest, Specimen Collection Kit
  • Modelo / Serial
    Lot Numbers: F0023, G0016, G0020, G0041, G0046, G0052, G0055, H008, H0011, H0036, H0044, H0053, I0043
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. || 8013, Provider Pack: 10 test (with lancet), || Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the || non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI || The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.
  • Manufacturer
    Immunetech Inc

Manufacturer

Immunetech Inc
  • Dirección del fabricante
    Immunetech Inc, 373 Vintage Park Dr Ste A, Foster City CA 94404-1139
  • Empresa matriz del fabricante (2017)
    Immunetech Inc
  • Source
    USFDA