Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Captia Syphilis-G Test Kit Product Usage: This is an enzyme Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) Due to Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Clark Laboratories, Inc. (dba,Trinity Biotech USA) directly.
Affected 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.
Quantity: 38 kits
Why Was This Recalled?
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA) has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report