Events

Retiro De Equipo (Recall) de Device Recall Siemens Healthcare Diagnostices Inc. MIcroScan MICroSTREP plus Type 1 B1027201 panels.

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 Siemens Healthcare Diagnostics, 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
    64699
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1272-2013
  • Fecha de inicio del evento
    2013-03-06
  • Fecha de publicación del evento
    2013-05-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116809
  • 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
    Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with a. agalactiae affecting multiple antimicrobial agents on microscan microbiology systems.
  • Acción
    Siemens Healthcare sent a Urgent Field Safety Notification letter dated March 6, 2013, to all affected customers of MicroScan MICroSTREP plus type 1, who process panels in a Walk Away System. The letter identified the product the problem and the action needed to be taken by the customer. As stated in our product Instructions for Use, test results should be interpreted in conjunction with the patients medical history, clinical presentation and other findings. We recommend discussing the content of this letter with your laboratory director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing for testing conducted in the last twelve months. Confirmation of receipt of this letter is required. Attached you will find a form indicating you have received and understood the information. We would greatly appreciate your assistance in notifying us that you have received the information by taking a moment to complete and return the form below. If you require further information or assistance, please contact your local Siemens Healthcare Diagnostics Representative. Please forward this notification to anyone to whom you may have distributed this product. We apologize for the inconvenience that this situation has caused. For further questions please call 1-800-677-7226 Option 1 (USA/Canada) Thank you for your patience and continued support.

Device

Device Recall Siemens Healthcare Diagnostices Inc. MIcroScan MICroSTREP plus Type 1 B1027201 pan...
  • Modelo / Serial
    All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution including Puerto Rico.
  • Descripción del producto
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. || .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA