Events

Retiro De Equipo (Recall) de Device Recall KWIKQC Gram Stain Slides

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 Microbiologics 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
    61998
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1936-2012
  • Fecha de inicio del evento
    2012-05-29
  • Fecha de publicación del evento
    2012-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109669
  • 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
    Quality control slides - Product Code LJG
  • Causa
    Microbiologics is recalling a number of lots of kwik-qc gram stain slides. this product gram negative control organism (e.Coli) is not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. this contamination could potentially lead to misdiagnosis and improper treatment of a patient.
  • Acción
    Microbiologics sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 30, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers not to use or distribute the affected product and to quarantine and return to the firm any remaining product. A Customer Response Form was attached for customers to complete and return to the firm. Contact Customer Service at 320-229-7057 for questions regarding this recall.

Device

Device Recall KWIKQC Gram Stain Slides
  • Modelo / Serial
    0353 - 0355, 0357 - 0363
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, KY, ME, MA, MI, MN, MS, NJ, NM, NY, PA, PR, SC, TX, VT, and VA. and the countries of SWITZERLAND, ITALY, ISRAEL, IRELAND, COLOMBIA, SWEDEN, INDIA, SINGAPORE, SERBIA, SAUDI ARABIA, CANADA, TAIWAN, SOUTH AFRICA, FRANCE, BRAZIL, MALTA, MACEDONIA, MALAYSIA, FINLAND, ECUADOR, VENEZUELA, REPUBLIC OF KOREA, NETHERLANDS, PERU, UNITED ARAB EMERITES, TURKEY, POLAND, and LEBANON.
  • Descripción del producto
    Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. || They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results.
  • Manufacturer
    Microbiologics Inc

Manufacturer

Microbiologics Inc
  • Dirección del fabricante
    Microbiologics Inc, 217 Osseo Ave N, Saint Cloud MN 56303-4452
  • Empresa matriz del fabricante (2017)
    Microbiologics Inc
  • Source
    USFDA