Events

Retiro De Equipo (Recall) de Device Recall ARCHITECT Intact PTH Calibrators

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
    67527
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1671-2014
  • Fecha de inicio del evento
    2014-02-12
  • Fecha de publicación del evento
    2014-05-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125677
  • 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
    Calibrator, secondary - Product Code JIT
  • Causa
    Abbott has confirmed that a performance shift in the architect intact pth assay has the potential to generate falsely elevated results on patient samples. results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. the issue may also impact your established architect intact pth reference ranges. abbott architect in.
  • Acción
    Product Information letters dated August 23, 2013 were sent to all direct accounts alerting the direct accounts to a positive bias observed in test results using some of the affected kits. The letter advised the direct accounts to take this information into account when interpreting patient results. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week) and to refer to Product Information Letter PI23AUG2013. Product Recall letters dated February 12, 2014 were sent to all direct accounts. The letter included instructions to: 1) immediately discontinue the use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to each customer's laboratory practices; 2) to continue Intact PTH testing at your laboratory, Abbott recommends that customers identify an alternate method for testing patient samples; 3) if further guidance is needed, please contact the customers's Abbott sales representative; 4) review the letter with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary, and that Abbott included a physician letter that you can use to notify your ordering physicians of this issue; 5) If the customer forwarded any product to other laboratories, please inform them of this Product Recall and provide a copy of the recall letter, customer reply, and physician letter to them; and, 6) complete and return the Customer Reply. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week).

Device

Device Recall ARCHITECT Intact PTH Calibrators
  • Modelo / Serial
    List Number: 8K25-01. Lot Numbers and Expiration Dates: Lot 00613I000, Expires 05 SEP 2014; Lot 01913C000, Expires 14 MAR 2014; Lot 01913K000, Expires 12 NOV 2014; Lot 02413E000, Expires 09 MAY 2014; Lot 01312K000, Expires 12 NOV 2013; Lot 00813A000, Expires 08 JAN 2014; Lot 01412H000, Expires 16 AUG 2013; Lot 00912F000, Expires 30 MAY 2013.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, ITALY, Jamaica, Japan, Jordan, Kenya, Korea (South Korea), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Panam¿, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Uruguay, Venezuela, Vietnam, and Yemen
  • Descripción del producto
    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. || Product Usage: || The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
  • 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