Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) Due to Through in-house routine real time stability monitoring of...
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
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.
Quantity: Domestic: 9 kits; Foreign: 26 kits
Why Was This Recalled?
Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
Where Was This Sold?
New York, Florida, Utah, and California plus foreign distribution to Spain and France
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