Events

Retiro De Equipo (Recall) de Device Recall iChem VELOCITY Automated Urine Chemistry System

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 Beckman Coulter 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
    79895
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1894-2018
  • Fecha de inicio del evento
    2018-03-29
  • Fecha de publicación del evento
    2018-04-27
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163822
  • 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
    Automated urinalysis system - Product Code KQO
  • Causa
    The strip provider modules (spm) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
  • Acción
    The recalling firm, Beckman Coulter/IRIS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated dated 3/26/2018 via email on 3/29/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Follow the on-board strip stability claims per Table 1 to determine the frequency at which the strips need to be changed. -Whenever the Strip Provider Module is accessed (i.e., opened or when loading strips), remove and discard the remaining on-board strips and desiccant before replenishing. -It is suggested that for the tests performed since the installation of the iChemVELOCITY/SPM housing assembly, consult with your Laboratory Director to determine whether a retrospective review of results is clinically warranted. -Complete and return the CUSTOMER RESPONSE FORM within 10 days by email to: Regulatory.Notifications@beckman.com, Please include FA-33476 iChemVELOCITY Automated Urine Chemistry System in e-mail subject field or by mail to:Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06 11800 S.W. 147th Avenue, P O BOX 169015, Miami, FL 33116-9015. -Beckman Coulter will contact you by phone to schedule a site visit for replacing the SPM on your instrument. -Beckman Coulter will be implementing process improvements to prevent this issue from recurring. If you have any questions regarding this notice, please contact: - From our website: http://www.beckmancoulter.com - By phone: call 800-854-3633 in the United States and Canada. ¿ -Outside the United States and Canada, contact your local Beckman Coulter representative.

Device

Device Recall iChem VELOCITY Automated Urine Chemistry System
  • Modelo / Serial
    Catalog 700-7176-001 - Serial numbers V04494 and CV04015;   Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: AL, IA, GA, and FL.
  • Descripción del producto
    iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. || The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA