Events

Retiro De Equipo (Recall) de Device Recall MicroScan Pos Breakpoint Combo Panel Type 23

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 Beckman Coulter 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
    72779
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0562-2016
  • Fecha de inicio del evento
    2015-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142202
  • 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
    Panels, test, susceptibility, antimicrobial - Product Code LTT
  • Causa
    Beckman coulter has confirmed falsely negative results for voges-proskauer (vp) (pale-pink/brown/colorless) with quality control (qc) american type culture collection (atcc) organism staphylococcus aureus atcc 29213 in a portion of affected lots of microscan pos combo and microscan pos breakpoint combo panels. the expected result is positive.
  • Acción
    The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use and discard any remaining inventory of lots listed; return the attached form for product replacement; retain your inventory of the other lot numbers of the panel types, as they are not impacted by this issue; discuss content of the letter with your laboratory director/staff, retain the notification as part of your laboratory QS documentation; if you have forwarded any of the affected products to another laboratory provide them a copy of the letter, and complete and return the enclosed Response Form within 10 days via mail to: Beckman Coulter, Inc., 1584 Enterprise Blvd., West Sacramento, CA 95691, Attn: Quality Systems & Compliance or Fax: 916-374-2119 or email: MicrobiologyCustomersHCUS@beckman.com. Customers with questions are instructed to contact their Customer Support Representative at http://www.beckmancoulter.com or by phone at (800) 677-7226 in US and Canada.

Device

Device Recall MicroScan Pos Breakpoint Combo Panel Type 23
  • Modelo / Serial
    2016-05-06 Part No. B1017-206
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
  • Descripción del producto
    MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA