Events

Retiro De Equipo (Recall) de Device Recall MultiAnalyte Urine 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
    60743
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0868-2012
  • Fecha de inicio del evento
    2011-08-23
  • Fecha de publicación del evento
    2012-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106374
  • 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
    Calibrators, drug mixture - Product Code DKB
  • Causa
    Multi analyte urine dau cutoff calibrator gives a decreased absorbance reading due to a loss of the bzo (oxazepam) analyte from the solution and may cause false positive readings.
  • Acción
    The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D; regarding stabilization of this analyte in solution in its calibrators of controls containing BZO. If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.

Device

Device Recall MultiAnalyte Urine DAU Cutoff Calibrator
  • Modelo / Serial
    Catalog number 0803; Lot 1101136K3, exp 1/28/13
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.
  • Descripción del producto
    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) || For in vitro diagnostic use only. || Lin-Zhi International, Inc.. || 670 Almanor Ave. || Sunnyvale, CA 94085 || intended use: Drug abuse detection.
  • 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