Events

Retiro De Equipo (Recall) de Single Analyte Urine DAU Control (5 m L

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 Lin-Zhi International 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
    66542
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0386-2014
  • Fecha de inicio del evento
    2013-10-03
  • Fecha de publicación del evento
    2013-11-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122570
  • 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
    Drug specific control materials - Product Code LAS
  • Causa
    Product catalog # a68825 norbuprenorphine 13 ng/ml level 2 controls gives a decreased concentration reading due to the degradation of the nbup analyte in solution.
  • Acción
    Beckman Coulter sent a Manufacturer Field Action Letter dated November 2013, to the one distributor. The letter identified the product the problem and the action needed to be taken by the customer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. If you have any questions regarding this notice, please contact our Customer Support Center ¿¿ Via our website, http://www.beckmancoulter.com/customersupport/support ¿¿ Via phone, call 1-800-854-3633 in the United States ¿¿ Outside the United States, contact your local Beckman Coulter Representative. We apologize for any inconvenience.

Device

Single Analyte Urine DAU Control (5 m L
  • Modelo / Serial
    Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution in CA.
  • Descripción del producto
    Single Analyte Urine DAU Control (5 m L || Norbuprenorphine, Level II control || For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. || Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. || Manufacturer: || Lin-Zhi International, Inc. || 670 Almanor Ave. || Sunnyvale, CA 94085 || The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
  • Manufacturer
    Lin-Zhi International Inc

Manufacturer

Lin-Zhi International Inc
  • Dirección del fabricante
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • Empresa matriz del fabricante (2017)
    Lin-Zhi International Inc.
  • Source
    USFDA