Events

Retiro De Equipo (Recall) de Device Recall DiaScreen Liquid Urine Controls

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 Assuramed.

¿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
    65980
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2196-2013
  • Fecha de inicio del evento
    2013-07-16
  • Fecha de publicación del evento
    2013-09-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121133
  • 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
    The products may have been stored at temperatures outside their required storage conditions.
  • Acción
    Independence Medical (im) sent an Urgent Product Recall letter dated July 16, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify and immediately cease the distribution of the recalled products, quarantine the recalled products, and contact the recalling firm at 800-860-8027 for instructions on how to return the recalled products. Consignees who further distributed the recalled products were requested to notify their customers of the recall. Consignees were also instructed to complete the Product Recall Acknowledgement Form and return the document by email to recall@indemed.com indicating receipt of the notification.Customers with questions were instructed to contact the product manufacturer for ProTime Disposable Cuvettes at 800-579-2255, DiaScreen Liquid Urine Controls at 800-818-8877, and Hemoccult II SENSA elite Dispensapak at 800-854-3633. For questions regarding this recall call 800-860-8027.

Device

Device Recall DiaScreen Liquid Urine Controls
  • Modelo / Serial
    Product Number: D76004;  Lots: All Lots;  Independence Medical Catalog Number: CJD76004
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
  • Descripción del producto
    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 || Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.
  • Manufacturer
    Assuramed

Manufacturer

Assuramed
  • Dirección del fabricante
    Assuramed, 1810 Summit Commerce Par, K, Twinsburg OH 44087
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA