FDA-Device2014-01-01Class II
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.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Sold states
USA Nationwide Distribution in the state of WA
Affected count
38 kits
Manufactured in
2823 Girts Road, N/A, Jamestown, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0572-2014Don't want to check this manually?
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