Retiro De Equipo (Recall) de Alere hCG Combo Cassette (20/10 mIU/mL) KIt

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..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Visual, pregnancy hCG, prescription use - Product Code JHI
  • Causa
    The firm initiated recall of alere" hcg combo cassette (20/10 miu/ml) kit pn 92215, lots hcg1110133 and hcg1110135, because an investigation has indicated a portion of these alere" hcg combo cassette (20/10 miu/ml) pn 92215 kit lots were incorrectly packaged with the alere" hcg cassette (20 miu/ml) pn 92210 product insert. the alere" hcg cassette (20 miu/ml) product insert contains information for.
  • Acción
    Alere initiated this recall by sending recall notification letters, titled "URGENT MEDICAL DEVICE RECALL", dated April 16, 2013 via via fax, email or direct mail. The letter informed customers of the product recalled, reason for recall, customer required action, and contact information, "Alere Technical Services at 866-216-0094 or by e-mail at". A verification form was attached to the notification letter.


  • Modelo / Serial
    Lot/Unit Codes: hCG1110133 & hCG1110135  Part Number: 92215  Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    United States Nationwide Distribution
  • Descripción del producto
    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. || Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
  • Manufacturer


  • Dirección del fabricante
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Empresa matriz del fabricante (2017)
  • 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