Events

Retiro De Equipo (Recall) de Device Recall mini VIDAS

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 bioMerieux, 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
    79993
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2428-2018
  • Fecha de inicio del evento
    2018-01-04
  • Fecha de publicación del evento
    2018-05-09
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164147
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Increase of events affecting performance regarding pump clogging and displacement of the color-coded spr label (dot). these performance issues could contribute to erroneous results for any assay performed on the vidas¿ and mini vidas¿ system due to a decrease of pipetted volume.
  • Acción
    Subsidiaries and distributors were initially notified of the recall on approximately 01/04/2018. U.S. customers were notified via letter on approximately 01/22/2018. On 03/28/2018 a follow-up notification was issued world-wide to customers to expand the scope. Instructions included to increase the frequency of the Quality Control VIDAS¿ (QCV¿) testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed, continue to conduct a visual inspection of the SPR¿ after each run (including patient sample test and QCV¿ test) to ensure that the dot on the SPR¿ is still in place, continue to perform External QC testing in accordance with laboratory policy and in compliance with Governmental Regulations & Accreditation Requirements, which includes CLIA, ensure the notification letter is distributed to and reviewed by all appropriate personnel, store the notification letter with the bioM¿rieux VIDAS¿ and /or miniVIDAS¿ documentation, and complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of the notice. For further questions, please call (314) 731-8694

Device

Device Recall mini VIDAS
  • Modelo / Serial
    Description, Reference No. (UDI No.): MINI VIDAS ANALYSER EU, 99174 (03573026111021); MINI VIDAS ANALYSER US, 99175 (03573026111045); MINI VIDAS 100-120 VOLT VDE/CE, 99733 (03573026118662); MINI VIDAS 200-240 VOLT VDE/CE, 99734 (03573026118655); MINI VIDAS BLUE 110 / 220 V, 99737 (03573026140441); MINI VIDAS ARKRAY ANALYZER, 99739 (03573026140465); MINI VIDAS, 410416 (03573026351656); MINI VIDAS, W1421 (03573026029180); MINIVIDAS INDUSTRY US, 421001 (03573026553319)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY. International distribution to Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Cape Verde, Chad, Chile, China / Hong Kong, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Mauretania, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Tanzania, Thailand, Togo, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zimbabwe.
  • Descripción del producto
    BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) || Product Usage: || the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Dirección del fabricante
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA