Bio-Rad Labs recalls Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test (Lot 18200A) due to elevated lot-to-lot bias in antibody levels. This may affect celiac disease testing accuracy but does not change clinical classifications for most samples.
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.
Bio-Rad Labs is recalling a specific lot of Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test kits because of a higher-than-expected bias between lots. This could slightly affect antibody level readings but typically won't change clinical results for most patients.
The test shows a higher level of antibodies than expected between lots due to manufacturing variations. However, the clinical classifications for most samples remain unchanged because the cut-off for the assay is 15 U/mL.
People who own or use the recalled lot (18200A) of Bio-Rad's tTG IgA test kits for celiac disease diagnosis. Those with the highest risk are individuals using the test for routine gluten sensitivity screening.
Check for the lot number 18200A on the test kit packaging. The product is labeled as 'Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test' with Material Number 425-2260.
Look for the lot number 18200A on the test kit packaging to confirm if it is recalled.
The recall is for a specific lot (18200A) with a higher-than-expected bias in antibody levels, but clinical classifications for most samples remain unchanged.
Check the lot number on the packaging. If it's 18200A, you do not need to take action as the recall does not require discarding or returning the product.
No, the recall is for a potential minor variation in test results, not a physical hazard.
We’ve drafted a message you can send Bio-Rad Labs to request your refund or repair — edit it as you like.
Subject: Recall Z-1800-2020 — Bio-Rad Labs Bio-Rad Labs Hello, I own a Bio-Rad Labs that is covered by recall Z-1800-2020 from Bio-Rad Labs. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
