Events

Retiro De Equipo (Recall) de Home Access Hepatitis C Check

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 Home Access Health Corp (HAHC).

¿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
    36429
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0150-2007
  • Fecha de inicio del evento
    2006-10-06
  • Fecha de publicación del evento
    2006-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48640
  • 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
    Hepatitis C Test (Home) - Product Code MZO
  • Causa
    Wrong expiration date; the kits were labeled with expiration/use by dates; that exceed the expiration dates of the sterile safety lancet component of the kit.
  • Acción
    Recall letters dated 10/6/06 were sent to the direct accounts via FedEx on the same date. The accounts were informed of incorrect Use By dates on the kits based on the lancet component of the kit, and that the lancet may not be sterile as of the printed Use By date on the kit. The letters listed the specific products and affected lot numbers shipped to the individual account, and requested them to examine their inventory for the affected product and return it via UPS to Home Access for replacement. No test results will be provided to any customer who uses the affected product after 10/31/06. Any questions were directed to 1-800-871-6046.

Device

Home Access Hepatitis C Check
  • Modelo / Serial
    UPC 0 83170 61000 2: lot 042715, exp May 2007; lot 042716, exp June 2007; lot 042717, exp June 2007; lot 042718, exp June 2007; lot 042719, exp August 2007; lot 042720, exp August 2007; lot 042721, exp August 2007; lot 042722, exp August 2007; lot 042723, exp October 2007; lot 042724, exp October 2007; lot 042725, exp October 2007; lot 042726, exp October 2007; lot 042727, exp October 2007; lot 052703, exp November 2007; lot 052704, exp November 2007; lot 052705, exp November 2007; lot 052706, exp November 2007; lot 052708, exp November 2007; lot 052709, exp January 2008
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5
  • Manufacturer
    Home Access Health Corp (HAHC)

Manufacturer

Home Access Health Corp (HAHC)
  • Dirección del fabricante
    Home Access Health Corp (HAHC), 2401 Hassell Rd Ste 1510, Hoffman Estates IL 60195-5241
  • Source
    USFDA