Device Recall Captia Syphilis IgG

  • Model / Serial
    Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the state of WA
  • Product Description
    Captia Syphilis-G Test Kit || Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Road, Jamestown NY 14701
  • Manufacturer Parent Company (2017)
  • Source
    USFDA