Device Recall Xpert CT/NG Urine Specimen Collection Kit GXCT/NGSWAB50

  • Modelo / Serial
    Part number: GXCT/NGURINE-50; Lot numbers: 23E104B, 23E104C, 26N128C, 26N1281, 29N142A, 29N142B, 29N142C, 29N142D, 29N142E, 29N142F, and 29N142G All with transfer pipette expiring end of May, June or July 2016. Collection kits expires in August, September, October of 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 Urine Specimen Collection Kit || Part number GXCT/NGURINE-50; || Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine 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