Events

Retiro De Equipo (Recall) de Device Recall VP 2000 Processor Heated Reagent Basins

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 Abbott Molecular.

¿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
    56284
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2313-2010
  • Fecha de inicio del evento
    2010-07-20
  • Fecha de publicación del evento
    2010-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93138
  • 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 Slide Stainer - Product Code KPA
  • Causa
    The vp2000 processor heated reagent basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.
  • Acción
    Abbott sent Urgent Product Recall letters dated 7/20/10 to the VP 2000 Processor customers on same date via FedEx, informing them that the heated reagent basins could crack along the bottom seam, have non-uniform coating of interior corners, warping of the aluminum housing or incorrect dimensions. These deficiencies could result in leakage or the inability to place the basins into the VP 2000 Processor, resulting in possible exposure to chemical reagents, a slippery floor hazard, and/or delay or failure to start a protocol run. An Abbott Molecular customer service representative will call them to coordinate replacement of all of their heated reagent basins before 10/31/10. Customers were to complete and return the Customer Reply form provided. Any questions were directed to their local Abbott Molecular Representative. *** A second recall letter was sent to all customers on 12/21/10 explaining that the VP 2000 heated reagent basins previously inspected and determined to be acceptable could develop a leak, and that they would be contacted by an Abbott Molecular Customer Service Representative or Field Service representative in early 2011 to coordinate replacement of all of their VP 2000 heated reagent basins. ***

Device

Device Recall VP 2000 Processor Heated Reagent Basins
  • Modelo / Serial
    All basins distributed since September 2008.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Australia, Belgium, France, Germany, India, Italy, Japan, Pakistan, Poland, Russia, Singapore, South Korea, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, and the United States.
  • Descripción del producto
    VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: || a) list 02J11-013, part number 30-144152 (replacement basins); || b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); || c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); || d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); || Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory.
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Dirección del fabricante
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA