Events

Retiro De Equipo (Recall) de Device Recall Boule Con Diff US Tri Pack

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 Clinical Diagnostic Solutions.

¿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
    63096
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0189-2013
  • Fecha de inicio del evento
    2011-03-24
  • Fecha de publicación del evento
    2012-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112535
  • 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
    Mixture, hematology quality control - Product Code JPK
  • Causa
    Clinical diagnostic solutions, inc. in plantation, fl recalled boule con diff us tri pack (product part 501-605, lot #1102-575 and 1102-576; product part 501-607, lot #1102-576; and product part 502-012, lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. the recall was initiated due to the receipt of a complai.
  • Acción
    Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328. For questions regarding this recall call 954-791-1773.

Device

Device Recall Boule Con Diff US Tri Pack
  • Modelo / Serial
    Product Part 501-605, Lot #1102-575 and Lot # 1102-576
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia
  • Descripción del producto
    Boule Con-Diff Hematology Control || For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
  • Manufacturer
    Clinical Diagnostic Solutions

Manufacturer

Clinical Diagnostic Solutions
  • Dirección del fabricante
    Clinical Diagnostic Solutions, 1800 Nw 65th Ave Ste 2, Plantation FL 33313-4544
  • Empresa matriz del fabricante (2017)
    Boule Diagnostics AB
  • Source
    USFDA