Events

Retiro De Equipo (Recall) de Phosphorus Reagent

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, 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
    66047
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0020-2014
  • Fecha de inicio del evento
    2013-08-12
  • Fecha de publicación del evento
    2013-10-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121322
  • 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
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • Causa
    Reagent lots 64736un12, 03991un13, 51611un13, 74805un12, and 03992un13 have incorrect expiration dates assigned by supplier.
  • Acción
    The firm, Abbott Laboratories, sent a "PRODUCT CORRECTION" letter dated August 12, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to update existing inventory and manually track the implanted lots with the corrected expiration dates listed in the letter; retain a copy of letter and if you have forwarded any of the lots listed to another laboratory, provide a copy of the letter to them. If you or any of your healthcare providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (422-2688). Customers outside the U.S., please contact your local area customer service.

Device

Phosphorus Reagent
  • Modelo / Serial
    For List Number: 7D71-22, Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014), 03991UN13 (Exp Date on Label is 01 APR 2014), and 51611UN13 (Exp Date on Label is 13 JUL 2014). For List Number: 7D71-31, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and 03992UN13 (Exp Date on Label is 01 APR 2014).
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.
  • Descripción del producto
    Clinical Chemistry Phosphorus Reagent || The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • 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