Events

Retiro De Equipo (Recall) de Calcium Arsenazo, CALA0250

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 SEPPIM SAS.

¿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
    66331
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0178-2014
  • Fecha de inicio del evento
    2013-09-04
  • Fecha de publicación del evento
    2013-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122064
  • 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
    Azo dye, calcium - Product Code CJY
  • Causa
    Calcium arsenazo reagent, reference cala-0250, is recalled due to complaint of plasma specimens report high results than serum.
  • Acción
    ELITech Group of Bothell, WA sent an Urgent: Product Recall Notice dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: " Laboratories must not use plasma for the determination of total calcium when using this product. The product can still be used to determine total calcium with serum sample. " ELITech Clinical Systems SAS has revised the package insert and kit box label for the CALCIUM ARSENAZO reagent reference CALA-0250. All mentions of the use of the plasma will be removed from the documentation. If you have inventory of CALCIUM ARSENAZO, reference CALA- 0250. All lots. in your laboratory, please discard the insert that you have and replace it with the insert enclosed with this notice. " If you have transferred any of this product to another location, please forward a copy this bulletin to that location. " All users receive CALCIUM ARSENAZO, CALA-0250, from distributors. To be certain everyone who is possibly affected by this change is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached receipt confirmation to Technical Support by fax (401-642-9003) within 48 hours of receipt. We apologize for the inconvenience that this situation can cause in your laboratories; we remain at your disposal for further information. If you have any questions, please contact Technical Support at 1-855-ELITECH (855-354-324) We thank you for your cooperation and the attention which you will give to this bulletin.

Device

Calcium Arsenazo, CALA0250
  • Modelo / Serial
    Lot numbers distributed in the US:  Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014.  Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including the states of KY and UT and the country of Sweden.
  • Descripción del producto
    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. || The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. || The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . || CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
  • Manufacturer
    SEPPIM SAS

Manufacturer

SEPPIM SAS
  • Dirección del fabricante
    SEPPIM SAS, ZONE INDUSTRIELLE, SEES France
  • Source
    USFDA