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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Société-mère du fabricant (2017)
  • Source
    USFDA