Events

Retiro De Equipo (Recall) de Device Recall VITROS 5,1 FS 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 Ortho-Clinical Diagnostics.

¿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
    38217
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1167-2007
  • Fecha de inicio del evento
    2007-05-17
  • Fecha de publicación del evento
    2007-08-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53171
  • 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
    in vitro diagnostic - Product Code JJE
  • Causa
    Software design. the firm received a customer complaint regarding a qualitative positive thc (cannabinoids) result obtained from a thc quality control fluid that was known to be negative when using vitros¿ chemistry products thc reagent. a second customer complaint was received a month later. ocd's investigation concluded that under specific circumstances, incorrect qualitative results for cannabi.
  • Acción
    On 5/17/07, OCD informed its foreign affiliates of the field correction by e-mail, and instructed them to inform their customers who received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents of this issue. On 5/18/07, all US OCD direct customers and end-use customers of consignees that received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents, were informed of the "field correction" by US Postal Service letter, provided with a new Assay Data Disk (ADD #5465), and were instructed to load it and recalibrate these assays, if necessary.

Device

Device Recall VITROS 5,1 FS Chemistry System
  • Modelo / Serial
    Software Version 2.2.1, Serial Numbers 34000121 to 34001377.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and Worldwide
  • Descripción del producto
    VITROS¿ 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS¿ Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626-5101
  • Source
    USFDA