Events

Retiro De Equipo (Recall) de Device Recall Piccolo Comprehensive Metabolic Panel

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 Abaxis, Incorporated.

¿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
    57321
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1066-2011
  • Fecha de inicio del evento
    2010-11-19
  • Fecha de publicación del evento
    2011-02-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95843
  • 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
    Nadh oxidation/nad reduction, alt/sgpt - Product Code CKA
  • Causa
    Abaxis has determined that during the manufacture of product lot 0396bc5 may report inaccurate values of alanine aminotransferase (alt) when used in the piccolo blood chemistry analyzer or piccolo xpress chemistry analyzer.
  • Acción
    The firm, Abaxis Inc., sent an "URGENT PRODUCT RECALL NOTICE" dated November 19, 2010, to all customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory of the lot for boxes #0665 or higher; if found, to discontinue use; contact Abaxis for immediate replacement; complete and return the enclosed PRODUCT RECALL RESPONSE form to Abaxis Technical Support via fax at 1-877-349-2087, and ensure that their laboratory staff is informed of this recall notice. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, or at medtechsupport@abaxis.com.

Device

Device Recall Piccolo Comprehensive Metabolic Panel
  • Modelo / Serial
    Lot Number: 0396BC5  Boxes # 686 - 834 and # 665-685.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries of: Kowloon and Germany.
  • Descripción del producto
    Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; || Product is manufactured and distributed by Abaxis, Incorporated, || Union City, CA || The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self¿contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.
  • Manufacturer
    Abaxis, Incorporated

Manufacturer

Abaxis, Incorporated
  • Dirección del fabricante
    Abaxis, Incorporated, 3240 Whipple Rd, Union City CA 94587
  • Empresa matriz del fabricante (2017)
    Abaxis Inc
  • Source
    USFDA