Events

Retiro De Equipo (Recall) de Device Recall Access Thyroglobulin Assay

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 Beckman Coulter 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
    71878
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2733-2015
  • Fecha de inicio del evento
    2015-07-28
  • Fecha de publicación del evento
    2015-09-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139264
  • 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
    System,test,thyroglobulin - Product Code MSW
  • Causa
    Beckman coulter, inc. is recalling access thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/ml.
  • Acción
    On 07/28/2015 the firm sent out customer notification letters via first class mail and e-mail. The firm's letter contained the following instructions: 1. Discard all Access Thyroglobulin reagent pack lots listed in the letter. 2. Evaluate Access Thyroglobulin results <10 ng/mL when using the reagent pack lot numbers listed to determine if controls and/or patients were higher than expected or did not match the clinical status of the patient. 3. At the discretion of the Laboratory Director, notify clinicians that it is possible the Access Thyroglobulin sample results reported by the laboratory were affected by this issue. The firm's notification letter requests that the information be shared with laboratory staff. If any affected products have been forwarded provide a copy of the letter to them. The firm requests that customers complete and return the Response Form within 10 days. Any questions contact the Customer Care Center: 1. From website at http://www.beckmancoulter.com 2. By phone: call 1-800-854-3633 in the United States and Canada. 3. Outside the United States and Canada, contact local Beckman Coulter representative

Device

Device Recall Access Thyroglobulin Assay
  • Modelo / Serial
    Catalogue number: 33860 Lot numbers: 431990 434727 430969 522896 523251  Expiration date: 10/31/16 12/31/16 08/31/16 04/30/17 05/31/17
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, Morocco, New Zealand, Oman, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam and Yemen.
  • Descripción del producto
    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA