Events

Retiro De Equipo (Recall) de Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set

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 Abbott Molecular.

¿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
    37363
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0595-2007
  • Fecha de inicio del evento
    2006-12-22
  • Fecha de publicación del evento
    2007-03-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50418
  • 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
    in vitro diagnostic - Product Code MVU
  • Causa
    The lsi d13s319 so/13q34 sa/cep 12 sg probe of the two mixture dna-probe was contaminated with lsi atm sg/p53 so probe. this contamination would result in 10 fish signals in each normal cell rather than the expected 6 fish signals in each normal cell.
  • Acción
    Abbott Molecular telephoned and/or sent recall letters to the Abbott FISH accounts on 12/22/06, advising them that an unexpected signal pattern with the Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 Probe was observed, confirmed and identified as a result of contamination in a subset of vials of D13S319 /CEP 12/13q34 from lot number 79500. This contamination results in 10 FISH signals in each normal cell (4 SO, 4 SG, 2 SA) rather than the expected 6 FISH signals in each normal cell (2 SO, 2 SG, 2 SA). The customers were advised that lot 80178 was also being included in the recall, and were requested to review the information carefully and assess the risk to their patient population; discontinue and destroy any unused product immediately; complete and return the enclosed reply form; review the information with laboratory personnel; and communicate the information to health care providers served in cases where the affected product were used and reported. Abbott Molecular provided replacement product for that product destroyed, upon receipt of the reply form. Any questions were directed to Abbott Molecular Technical Service at 800-553-7042, option 2.

Device

Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set
  • Modelo / Serial
    list 05J83-001, part number 32-191025, lot numbers 79500, exp. 8-9-08 and 80178, exp.10-16-08
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA, Austria, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, and the United Kingdom.
  • Descripción del producto
    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; || The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Dirección del fabricante
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA