Events

Retiro De Equipo (Recall) de ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT)

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 Atossa Genetics, 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
    66433
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0042-2014
  • Fecha de inicio del evento
    2013-09-19
  • Fecha de publicación del evento
    2013-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122387
  • 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
    Instrument, biopsy - Product Code KNW
  • Causa
    Atossa genetics is recalling forecyte breast health test, mammary aspiration specimen cytology test (masct) due to concerns raised by the u.S. food and drug administration (fda) in a warning letter received by atossa in february 2013. the fda raised concerns about (1) the current instructions for use (ifu); (2) certain promotional claims used to market these devices; and (3) the need for fda cl.
  • Acción
    Atossa Genetics Inc. issued a press release to announce a voluntary recall on October 4, 2013. The firm started sending out the URGENT - VOLUNTARY PRODUCT RECALL NOTIFICATION ForeCYTE Breast Health Test; Mammary Aspiration Specimen Cytology Test (MASCT) RESPONSE REQUIRED letter to consignees on October 7, 2013. The letter identified the affected product, problem and actions to be taken. The firm initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. The MASCT device has not been cleared by the FDA for the screening or diagnosis of breast cancer. In addition, the ForeCYTE Breast Health Test has not been cleared or approved by the FDA for any indication. The ForeCYTE Breast Health Test and the MASCT device are not a replacement for screening mammograms, diagnostic imaging tests, or biopsies. Patients should follow the recommendations and instructions of their physician with respect to breast cancer screening and diagnosis. Distributors are instructed to notify downstream customers and physicians are instructed to notify patients who have been tested using the MASCT and/or ForeCYTE systems. Consignees should return the Response Form back to Atossa. Distributors and customers should call 800-219-4629 to obtain a Returned Materials Authorization (RMA) number to return affected products. Customers with questions about this voluntary recall or Atossa's products, or would like assistance with the recall documentation may contact Atossa at 1-888-219-4629. Any problems experienced with the use of this product may be reported to the FDA at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, Online (form available to fax or mail), or call FDA 1-800-FDA-1088.

Device

ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT)
  • Modelo / Serial
    ALL LOTS
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of: AL, CA, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, ND, NJ, NV, NY, OK, PA, SC, TN, TX, UT, VA, WA, Washington DC, and Puerto Rico.
  • Descripción del producto
    Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. || The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: || PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. || PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. || THE MASCT SYSTEM KIT CONSISTS OF: || 1. MASCT Breast Pump; || 2. Instructions for Use (IFU); || 3. Heating Pad; || 4. Timer; || 5. Saccomono's Fixative; || 6. Nu Prep Gel; || 7. Welcome and Training Materials Coversheet; || 8. MASCT System Order Form; || 9. ForeCYTE Training Video DVD; || 10. MASCT System Instructions with pictures - pink; || THE PATIENT SAMPLE KIT CONSISTS OF: || 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); || 2. Instructions for Use (IFU); || 3. Two (2) specimen collection devices; || 4. Two (2) breast bags for transporting the specimen collection container; || 5. Barcode labels; || 6. Saccomono's Fixative; || 7. Nu Prep Gel; || 8. MASCT System package insert; || 9. ForeCYTE Test Requisition Form; || 10. Patient Information Sheet; || 11. Atossa Patient Information; || 12. FED EX Clinical PAK; || 13. MASCT System Order Form; || 14. FED EX Pouch; || 15. FED EX Airbill; || Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
  • Manufacturer
    Atossa Genetics, Inc.

Manufacturer

Atossa Genetics, Inc.
  • Dirección del fabricante
    Atossa Genetics, Inc., 1616 Eastlake Ave E Suite 4411, Seattle WA 98102-3788
  • Empresa matriz del fabricante (2017)
    Atossa Genetics, Inc.
  • Source
    USFDA