Events

Retiro De Equipo (Recall) de Device Recall AutoMate TM Sample Processing 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
    55207
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2212-2011
  • Fecha de inicio del evento
    2009-05-07
  • Fecha de publicación del evento
    2011-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90304
  • 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
    Equipment laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
  • Causa
    The recall was initiated because beckman coulter has confirmed an issue with the automate sample processing systems. if during the recovery from error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube/input tray information will become mismatched for samples being loaded onto the automate.
  • Acción
    Beckman Coulter sent an Urgent Product Corrective Action letter dated May 7, 2009, with a Fax Back Response Form (sent by US mail) to all customers who received the AutoMate Sample Processing System. The letter identified the product, the problem and a workaround to correct the problem. Customers were instructed to take the following steps: If the stuck sample carrier is moved backwards during recovery from this error, the sample tube/input tray information will become mismatched. Figure 2 in the PCA letter shows the AutoMate viewed from the rear. Sequence 1 to 3 depicts the error recovery issue. The sample is loaded, but cannot move along the track. As the sample attempts to move along the track, it is captured by the track stopper (not seen) below the track. Error 81201001 will be displayed at the console with the following description: The stopper (SL01) did not stop the sample tube carrier.If the stopper or an operator forces the sample backward along the line, it will cause the information mismatch. If you encounter this scenario, do not move the carrier backward to the loading position. See Figure 3 in the PCA letter. Recovery from Error 81201001: 1. The normal recovery for error 81201001 is to move the sample carrier forward. If there is no room to do so in the Input module, extra steps must be taken for the carrier to move forward. a. Resume the module by performing error recovery on the Hardware Error Recovery screen at the console. b. Continue the console error recovery process until a carrier is released from BR01, thereby creating space for the stuck carrier to be pushed forward. c. Move the stuck sample carrier forward d. Once again, resume the module by performing error recovery on the Hardware Error Recovery screen. (The error should not return again) Recovery if Symptoms are Observed: 1. If the incorrect processing described above is observed, the system must be stopped immediately and shut down. All samples m

Device

Device Recall AutoMate TM Sample Processing System
  • Modelo / Serial
    Lot number - N/A. P/N - A20745.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including VA KY and CA
  • Descripción del producto
    AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate || The AutoMate system prepares sample tubes for diagnostic testing and for storage. The AutoMate system contains an automated track that connects to Input/Output, Centrifuge, Serum Level Detection, Decapper, and Output modules. The AutoMate TM 800 model also contains and Aliquot module.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

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