Bio-Rad Autoimmune EIA Anti-Tissue Transglutaminase IgA Test Recalled for Lot Bias
Bio-Rad Labs is recalling 376 units of the Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test, Lot 18200A, due to elevated lot-to-lot bias affecting antibody measurements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that clinical classifications for most samples would remain unchanged, indicating a low-risk contamination or minor labeling/measurement error scenario without reported injuries.
Plain-English summary
Bio-Rad Labs is recalling 376 units of the Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test, Material Number 425-2260, Lot Number 18200A. The product is an assay used as an aid in the diagnosis of celiac disease and is intended to be used in conjunction with other serological tests and clinical findings.
The recall was initiated because an elevated lot-to-lot bias was observed for this specific lot when compared to a previous lot of the product. The source text notes that this bias is largely due to samples with higher levels of antibodies. However, with the assay's cut-off set at 15 U/mL, the clinical classifications for most samples would remain unchanged.
The affected units were distributed nationwide in the United States, including the states of Arizona, New York, Louisiana, Florida, California, Texas, Iowa, Mississippi, Utah, and Illinois. The recall is classified as Class II by the FDA. Users should check their inventory for the specific lot number and contact Bio-Rad Labs for further instructions.
The recalled product
- Product
- 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 clinic
- Manufacturer
- Bio-Rad Labs
- Hazard
- Affected units
- 376
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number 425-2260
- Lot Number 18200A: UDI 00847817018336.
Distribution
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