Events

Retiro De Equipo (Recall) de Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator

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
    67607
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1270-2014
  • Fecha de inicio del evento
    2014-02-18
  • Fecha de publicación del evento
    2014-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125829
  • 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
    Enzyme immunoassay, opiates - Product Code DJG
  • Causa
    Customer reported that the synchron nbup cutoff calibrator (10 ng/ml) could not be qualified through quality control testing. the cutoff calibrator was recovering at a concentration close to the nbup control level 1 (7 ng/ml).
  • Acción
    Lin-Zhi International sent a Recall letter dated February 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters acknowledge that Lin Zhi was notified by the customer that the product could not be qualified and that this was confirmed by Lin-Zhi internal testing. Letters request that the distributor notify all customers of the situation and ask them to destroy any remaining product from the affected lots. the root cause is identified and letters also state that a corrective action has been implemented to prevent future problems. Questions may be directed to Lin Zhi International at 408-732-3856.

Device

Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator
  • Modelo / Serial
    Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including CA.
  • Descripción del producto
    Single Analyte DAU Calibrator (5 mL) || Norbuprenorphine: Cutoff Calibrator; || IVD - for in vitro diagnostic use only; || Lin-Zhi International || Sunnyvale, CA || The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
  • 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