Device Recall Captia (TM) Syphilis IgM Capture

  • Model / Serial
    Lot 033, expiry date 30 November 2014
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    New York, Florida, Utah, and California plus foreign distribution to Spain and France
  • Product Description
    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Rd, Jamestown NY 14701-9666
  • Manufacturer Parent Company (2017)
  • Source