Events

Retiro De Equipo (Recall) de Device Recall Ammonia L3K Assay

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 Sekisui Diagnostics P.E.I. 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
    75818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1078-2017
  • Fecha de inicio del evento
    2016-11-29
  • Fecha de publicación del evento
    2017-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151386
  • 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
    Enzymatic method, ammonia - Product Code JIF
  • Causa
    Certain lots are showing an atypical decrease in optical density (od) over time, which may result in an impact to performance at the high end of the linear range.
  • Acción
    Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K¿ reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK¿ from the listed lot numbers; Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email PEIDiagnosticTechnical@sekisui-dx.com.

Device

Device Recall Ammonia L3K Assay
  • Modelo / Serial
    Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
  • Descripción del producto
    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 || For the IN VITRO quantitative measurement of ammonia concentration in plasma
  • Manufacturer
    Sekisui Diagnostics P.E.I. Inc.

Manufacturer

Sekisui Diagnostics P.E.I. Inc.
  • Dirección del fabricante
    Sekisui Diagnostics P.E.I. Inc., 70 Watts Ave, Charlottetown Canada
  • Empresa matriz del fabricante (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA