Events

Retiro De Equipo (Recall) de MultiAnalyte Urine DAU Intermediate 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
    60757
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0847-2012
  • Fecha de inicio del evento
    2011-10-11
  • 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=106403
  • 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
    Catalog # 0804 multi-analyte urine dau intermediate calibrators were incorrectly labeled and mistakenly filled with catalog # 0805 dau high calibrators.
  • Acción
    Lin -Zhi International sent a Recall letter dated October 11, 2011, and a e-mail to all affected customers. This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. The customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available. For further questions please call (408) 732-3856.

Device

MultiAnalyte Urine DAU Intermediate Calibrator
  • Modelo / Serial
    Catalog 0804; lot number 1101138K2, exp 1/28/2013
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and TX. and the country of Germany,
  • Descripción del producto
    Multi-Analyte Urine DAU Calibrator (15 mL); || Multi-Analyte,Intermediate Calibrator; || for in-vitro diagnostic use only. || Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. || Drug abuse testing || Lin-Zhi International, Inc.' || 670 Almanor Ave. || Sunnyvale, CA 94085.
  • 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