Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Trinity Biotech Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) Due to The Positive Control for the Captia Varicella-Zoster Virus...
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 VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Quantity: 810 kits
Why Was This Recalled?
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
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