Events

Retiro De Equipo (Recall) de Device Recall Architect Sirolimus Reagent Pack

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 Laboratories.

¿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
    55871
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2172-2010
  • Fecha de inicio del evento
    2010-05-27
  • Fecha de publicación del evento
    2010-08-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92107
  • 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
    Sirolimus test system - Product Code NRP
  • Causa
    The architect sirolimus assay lot 80162m100 is exhibiting higher than normal reports of barcode read errors.
  • Acción
    Abbott sent a "Product Recall" letter dated May 27, 2010, to all customers receiving the affected lot of reagent. The customers were informed of the increased frequency of barcode read errors due to the print quality of the barcode label. The following error codes have been observed for some kits within the lot: 4000 - Unable to read reagent bar code in position (x) on (y) carousel, 0208 - Reagent carousel scan error, and 2011 - Extra reagent bottle detected in position (x) on (y) carousel. The customers were requested to determine if they are currently using or have inventory of lot 80162M100, discontinue use of and destroy any remaining inventory of the lot, and retain a copy of the letter for their laboratory records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688. Customers outside the U.S., please contact your local Customer Service representative.

Device

Device Recall Architect Sirolimus Reagent Pack
  • Modelo / Serial
    Lot 80162M100, Expiry Date May 03, 2011
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.
  • Descripción del producto
    Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25. || The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Dirección del fabricante
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA