Events

Retiro De Equipo (Recall) de Device Recall Cyto Jar Fixative

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 Leica Biosystems Richmond 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
    61276
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1331-2012
  • Fecha de inicio del evento
    2012-02-20
  • Fecha de publicación del evento
    2012-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107702
  • 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
    Preservative, cytological - Product Code LEA
  • Causa
    Product was distributed with the incorrect lot number and expiration date. the lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for this product.
  • Acción
    The firm, Leica Microsystems, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 17, 2012, via FedEx on February 20, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken. A second letter was sent to the customers on February 29, 2012, clarifying that the incorrect lot number and expiration date was 073014, and should have been 073013. The customers were instructed to discontinue use of the product; return the product and complete and return the enclosed Acknowledgement Form via fax to 815-678-2216 within one week of receiving the notification. If you have any questions, contact the Regulatory Affairs Manager at toll free (800) 225-8867 or email: richmond@leica-microsystems.com.

Device

Device Recall Cyto Jar Fixative
  • Modelo / Serial
    item #3801825, reorder #01825, lot #073013
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: Michigan, Missouri and New York.
  • Descripción del producto
    Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA || The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens.
  • Manufacturer
    Leica Biosystems Richmond Inc.

Manufacturer

Leica Biosystems Richmond Inc.
  • Dirección del fabricante
    Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA