Events

Retiro De Equipo (Recall) de Device Recall Drugs of abuse urinalysis (DAU) cTHC (Cannabinoid) Control Level 2 (62.5 ng/ml)

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
    67521
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1179-2014
  • Fecha de inicio del evento
    2014-02-06
  • Fecha de publicación del evento
    2014-03-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125667
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • Causa
    Product catalog #s 0007c cannabinoid 37.5 ng/ml control level 1 and 0008c cannabinoid 62.5 control level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.
  • Acción
    Lin-Zhi International, sent an Recall letter dated February 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall letter identified the product by catalog number and product description as well as lot numbers. The reason for recall is explained and that the issue was confirmed by Lin Zhi Quality Control. The 2 affected lots were made with unexpired but dated secondary stock that is the cause of the problem. Lin Zhi requests that customers inform laboratories and customers to properly dispose of any of the affected lots that are still in use or unopened. Lin Zhi should be notified of the amounts for credit. Questions should be directed to 408-732-3883.

Device

Device Recall Drugs of abuse urinalysis (DAU) cTHC (Cannabinoid) Control Level 2 (62.5 ng/ml)
  • Modelo / Serial
    Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
  • Descripción del producto
    Cannabinoids DAU Calibrator Control Level 1 || (62.5 ng/mL) || This solution is prepared from non-sterile urine and should be handled as potentially infectious. || IVD; || The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free || matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿¿ 10% by GC/MS or LC/MS analysis. || Lin Zhi International inc. || Sunnyvale, CA 94085 || The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
  • 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