Events

Retiro De Equipo (Recall) de Device Recall Sm ELISA Test System

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 Zeus Scientific 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
    49438
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1089-2009
  • Fecha de inicio del evento
    2008-08-19
  • Fecha de publicación del evento
    2009-03-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-04-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73329
  • 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
    Antinuclear Antibody Immunological Test System - Product Code LJM
  • Causa
    The calibrator value is printed incorrectly on the sm elisa test system, lot # 08041819. the calibrator value (cv) printed on the label is 102; the correct cv should read 266.
  • Acción
    Urgent Recall Notice letters were sent out by Federal Express night mail on August 19, 2008 to all direct account. Wampole (Inverness) will notify their customers in a separate letter. Recall letters explained the reason for the recall and that the product does meet the company's criteria when it is used qualitatively to interpret index values or OD rations as outlined in the kit package insert. Customers are advised in the letter that the Calibrator Value of 102 is incorrect and that it should be 266. Instructions to correctly express the specimen results using specimen and calibrator OD values semi-qualitatively as Unit Values and the Calibrator Value (CV) or 266 are included. Letters also state that results for all patients using the incorrect CV of 102 should be recalculated using the correct CV of 266. All letters included a fax back form indicating that they have received the recall notification, have notified customers to correct the CV value for the Semi-Quantitative Conversion and have notified customers that have received the kit to correct the Semi-Quantitative Conversion of Optical Density to AAU/mL for the affected lot number of the Sm ELISA Test System.

Device

Device Recall Sm ELISA Test System
  • Modelo / Serial
    Lot number 08041819, Exp. 11/2009;, Lot number 08041811, Exp. 11/2009 (Inverness Medical - Wampole)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Sm ELISA Test System || Product number 2Z2831G and Product number 43270CE || Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. || Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. || Also manufactured for Wampole Laboratories, Princeton, NJ 08540 || Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.
  • Manufacturer
    Zeus Scientific Inc

Manufacturer

Zeus Scientific Inc
  • Dirección del fabricante
    Zeus Scientific Inc, 200 Evans Way, Somerville NJ 08876-3767
  • Source
    USFDA