Events

Retiro De Equipo (Recall) de Device Recall Vysis Paraffin Pretreatment Reagent Kit II

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
    54190
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1147-2010
  • Fecha de inicio del evento
    2010-01-22
  • Fecha de publicación del evento
    2010-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87798
  • 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
    pathology fixative - Product Code KEO
  • Causa
    The paraffin pretreatment reagent kits do not have any hazardous or msds information included in their labeling.
  • Acción
    Abbott Molecular sent Field Correction Letter/Urgent Field Safety Notice letters dated 1/21/10 to the Paraffin Pretreatment Regent Kit customers on 1/22/10, informing them that the MSDA symbology for hazardous and corrosive material is missing from the Paraffin Pretreatment Regent Kit II and Paraffin Pretreatment Regent Kit III labels. The information is missing from the vial label, kit label and package insert. The letter listed the risk and safety statements that should be included in the package insert, and advised the customers should use the kits in accordance with the listed risk and safety statements. The accounts were instructed to review this information with laboratory personnel and retain the letter for future reference, making copies of the letter and placing them in each kit in stock. Any questions were directed to their local Abbott Molecular Representative. Abbott Molecular plans to telephone each customer to ensure that they have received the letter and have disseminated the information to their laboratory personnel.

Device

Device Recall Vysis Paraffin Pretreatment Reagent Kit II
  • Modelo / Serial
    list 07J02-002, part number 32-801210, lot numbers 420563, 420008 and 418294
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.
  • Descripción del producto
    Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic.
  • Manufacturer
    Abbott Molecular

Manufacturer

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