Retiro De Equipo (Recall) de Device Recall Coulter Preplus 2

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Causa
    The recall was initiated after erroneous, though potentially credible, results due to intermittent reagent level sense failures could be generated. during these failures, the instrument fails to produce a warning that a reagent vial is low or out of reagent. the low or absent levels of reagent used during these failures may lead to insufficient antibody being dispensed into a daughter tube there.
  • Acción
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated January 18, 2011 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1) Follow PrepPlus 2 Instructions for Use (Part # 4277264-BA) for all reagent and specimen requirements prior to initiating a run on the PrepPlus 2 including: A) Ensuring all dead volume requirements for reagents as indicated in 7.11 and 7.12 of the Sample Processing sections and 12.2 of the Troubleshooting Guide. Appropriate volume of reagent in all vials per the planned number of tests to be run must contain at least the volume listed on the Worklist (plus an additional 10% of the full volume of the container to account for dead volume)". B) Ensuring specimen processing dead volume requirements are met as indicated in section B of Specimen Tube Size to ensure the minimum amount of specimen needed. C) Monitoring for any foaming/bubble accumulation in the reagent vial. 2) A review of all clinically relevant results generated from samples prepared on the system be conducted. Abnormally dim or unexpected negative sample staining patterns should be reviewed to ensure correlation with clinical symptomatology and other diagnostic data. If the clinical information Is in accordance with the clinical data released, the validity of the results could be considered accurate and no retrospective action may be needed. If inconsistent data is observed, please adhere to good laboratory practices within your institution and consider data re-analysis and re-testing. The customers were also instructed to share this information with their laboratory staff and retain it as part of their laboratory Quality System documentation; if they have forwarded any of the affected product(s) listed above to another laboratory, provide a copy of the letter to them, and complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM via fax to: (786)639-7500/7501/750


  • Modelo / Serial
    Part #378600
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA and countries including: Australia, Barbados, Belarus, Belgium, Canada, Croatia, France, Germany, Ireland, Italy, Japan, Malawi, Mozambique, Namibia, Poland, Puerto Rico, Russian Federation, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Ukraine, United Kingdom, Zambia.
  • Descripción del producto
    Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting system. || PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. The PrepPlus 2 is a compact, fully automated sample work station which can be programmed to perform a wide variety of liquid handling operations where volumes required range from 5 uL to 1000 uL.
  • Manufacturer


  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
  • Source