Events

Retiro De Equipo (Recall) de Device Recall OPTI LION EPlus

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 OPTI Medical Systems, 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
    58272
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2558-2011
  • Fecha de inicio del evento
    2011-03-15
  • Fecha de publicación del evento
    2011-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98847
  • 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
    Electrode, ion-specific, chloride - Product Code CGZ
  • Causa
    The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
  • Acción
    OPTIMedical Systems sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 15, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were notified by letter via e-mail and fax. Customers were instructed to discontinue use of the product and to return any unused product to OPTI Medical Systems, Inc. Customers outside the U.S. were instructed to destroy unused product and certify the destruction on the enclosed Recall Response Card. The Response Card was to be completed and returned to OPTI Medical Customer Service via fax. OPTI Medical Systems will replace the cassettes they have with product from another lot. Customers were instructed to contact the Technical Support Department at 1-800-490-6784 for questions relating to this notice.

Device

Device Recall OPTI LION EPlus
  • Modelo / Serial
    Lot numbers 038811 and 102812
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-- USA (nationwide) including states of CA and VA, and countries of India, Lebanon, Philippines, Sweden, Venezuela and Vietnam.
  • Descripción del producto
    OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). || Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.
  • Manufacturer
    OPTI Medical Systems, Inc

Manufacturer

OPTI Medical Systems, Inc
  • Dirección del fabricante
    OPTI Medical Systems, Inc, 235 Hembree Park Dr, Roswell GA 30076-5738
  • Empresa matriz del fabricante (2017)
    IDEXX Laboratories, Inc.
  • Source
    USFDA