Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test Recalled by Bio-Rad Labs Due to An elevated lot-to-lot bias was observed for Autoimmune...
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 Bio-Rad Labs directly.
Affected Products
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
Quantity: 376 units
Why Was This Recalled?
An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bio-Rad Labs
Bio-Rad Labs has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report