Reported May 6, 2020 · Completed
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product…
Bio-Rad Labs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Rad Labs · 5500 E 2nd St · Benicia, CA · 94510-1020
Is this the product you have?
- Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260
- Lot number 18200A - Product UsageThe 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
- Lot codes and dates
- Catalog Number 425-2260
- Lot Number 18200AUDI 00847817018336
- Amount recalled
- 376 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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