Device Recall Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit GXCT/NGSWAB50

  • Modelo / Serial
    Part number: CT/NGSWAB-50: Lot numbers: 46A202C, 46A202D, 46A202E, 46A202F, 46A202G, Flock swab expires end of July 2015. Kit expires October 2015. Lot numbers 26N121H, and 28N134D.- Cleaning swabs expire end of June 2016. Kits expires November 2016.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide, including North Mariana Islands, Aruba, Canada, Chile, Colombia, Costa Rica, Cyprus, Guam, Guatemala, Italy, Malawi, Micronesia Federated States, Panama, San Marino, South Africa, Spain, Switzerland, and Zimbabwe.
  • Descripción del producto
    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: || Part number CT/NGSWAB-50; || Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA