Events

Retiro De Equipo (Recall) de Triage Cardiac Panel

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 Biosite 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
    51925
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1391-2009
  • Fecha de inicio del evento
    2009-04-27
  • Fecha de publicación del evento
    2009-05-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81652
  • 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
    Cardiac Markers Test - Product Code MMI
  • Causa
    The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin i and myoglobin, possibly resulting in missed or incorrect diagnosis.
  • Acción
    The recall was initiated with "Urgent Medical Device Recall" notices, dated 4/28/2009, with attached "Customer/Distributor Verification Form" being sent to the affected customers via fax, e-mail or direct mail on 04/28/2009. Customers were informed of the reason for the recall and instructed to immediately discontinue all use of the listed products and discard all affected product in accordance with your their regulations. The customers were give two options; "Option 1: Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice, to indicate the number of kits discarded from your inventory and product replacement will be sent to you. Option 2: Contact inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt. A representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you." Customers were also provided telephone, fax and e-mail contact information for Biosite should they have any questions about the information contained in the recall notification.

Device

Triage Cardiac Panel
  • Modelo / Serial
    Lot Number W44467B
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. || Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determination of myoglobin, creatine kinase MB fraction (CK-MB), and troponin I in EDTA whole blood and plasma specimens. These three cardiac biomarkers are used as an aid in the diagnosis of myocardial infarction (injury).
  • Manufacturer
    Biosite Inc

Manufacturer

Biosite Inc
  • Dirección del fabricante
    Biosite Inc, 9975 Summers Ridge Rd, San Diego CA 92121
  • 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