Events

Retiro De Equipo (Recall) de KASSAY Alpha1 Microglobulin Reagent

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 Kamiya Biomedical Company, LLC.

¿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
    50074
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0923-2011
  • Fecha de inicio del evento
    2008-09-17
  • Fecha de publicación del evento
    2011-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74651
  • 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
    Alpha-1 microglobulin, antigen, antiserum, control - Product Code MGA
  • Causa
    Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
  • Acción
    Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed. For questions regarding this recall call 1-800-222-0342.

Device

KASSAY Alpha1 Microglobulin Reagent
  • Modelo / Serial
    Lot number 418041, catalog number KAI-056.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.
  • Descripción del producto
    K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. || The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
  • Manufacturer
    Kamiya Biomedical Company, LLC

Manufacturer

Kamiya Biomedical Company, LLC
  • Dirección del fabricante
    Kamiya Biomedical Company, LLC, 12779 Gateway Dr S, Tukwila WA 98168-3308
  • Empresa matriz del fabricante (2017)
    Kamiya Biomedical Company Llc
  • Source
    USFDA