Events

Retiro De Equipo (Recall) de Device Recall lmmunalysis EDDP Urine Control Set 1

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 Alere San Diego Inc. DBA Immunalysis Corporation.

¿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
    80096
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2140-2018
  • Fecha de inicio del evento
    2017-11-28
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164551
  • 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, methadone - Product Code DJR
  • Causa
    The high (125 ng/ml) control does not meet specification - it has been confirmed to produce values below 100 ng/ml when run on validated clinical chemistry analyzers, which is below the 100 ng/ml cutoff of the eddp specific urine enzyme immunoassay with which this control is utilized.
  • Acción
    On November 28, 2017, the firm sent their customer notifications of the recall stating the following: CUSTOMER REQUIRED ACTION 1. If you have product in your possession: " Immediately discontinue use and/or sale of affected product lot and place in quarantine. " Complete the enclose Customer Verification Form, within 10 days, indicating the quantity of product you have discarded or will return to lmmunalysis. " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com " Upon receipt of your Customer Verification Form, we will initiate shipment of replacement product in the quantity indicated on the form and, if applicable, will contact you to arrange product return. " Return product as directed. 2. If you have no remaining product in your possession: " Complete the enclosed Customer Verification Form, within 10 days, indicating "We do not have any affected product - it has been consumed". " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com 3. Share this information with your staff and retain this notification as part of your records. Please complete this form and return within 10 days even if you do not have any remaining product. Send form to lmmunalysis at Fax 909-482-0850 or by e-mail to rtimbang@immunalysis.com For further questions, please call (207) 730-5738.

Device

Device Recall lmmunalysis EDDP Urine Control Set 1
  • Modelo / Serial
    Part Number: 3006-5, Lot Number: EK16135
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
  • Descripción del producto
    lmmunalysis EDDP Urine Control Set 1 || The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.
  • Manufacturer
    Alere San Diego Inc. DBA Immunalysis Corporation

Manufacturer

Alere San Diego Inc. DBA Immunalysis Corporation
  • Dirección del fabricante
    Alere San Diego Inc. DBA Immunalysis Corporation, 829 Towne Center Dr, Pomona CA 91767-5901
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA