Events

Retiro De Equipo (Recall) de Device Recall Staphaurex Plus 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 Remel, 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
    51131
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1400-2009
  • Fecha de inicio del evento
    2008-11-18
  • Fecha de publicación del evento
    2009-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78760
  • 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
    Antistreptolysin - Titer/Streptolysin O Reagent - Product Code GTQ
  • Causa
    These lots may exhibit false positive reactions with strains of staphylococcus epidermidis that may result in the mis-identification of staphylococcus aureus.
  • Acción
    Consignees were notified of the recall via letter dated 11/20/08 explaining the reason for recall and requesting any remaining units from the lots be discarded. A Product Inventory Checklist was enclosed to report the amount of product remaining in their inventory. Any non-responding consignees were contacted via telephone during the period of 12/30/08 to 1/11/09 to ensure the effectiveness of the recall. When the recall was expanded to include additional lots, the recalling firm issued an Important Medical Device Customer Recall Notice letters dated 3/16/09 again explaining the reason for recall. The letter also asked consignees to review their inventories for the product lots indicated and requested that remaining units from the lots be discarded. This letter also had a Product Inventory Checklist enclosed for completion.

Device

Device Recall Staphaurex Plus Kit
  • Modelo / Serial
    Lot No. J311510, Expiry Date 2009.04.30, and Lot J477610, Expiry Date 2009.10.31;  Lot No. J311610, Expiry Date 2009.04.30; Lot No. J477710, Expiry Date 2009.10.31; and J359510, Expiry Date 2009.07.31
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England.
  • Manufacturer
    Remel, Inc

Manufacturer

Remel, Inc
  • Dirección del fabricante
    Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA