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.
Check against the official notice below — it lists the full affected range.
Bio-Rad Laboratories is recalling Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test kits (Material Number 425-2260, Lot Number 18200A) used to aid in diagnosing celiac disease. An elevated lot-to-lot bias was detected in this lot compared to a previous lot, with the difference being most significant in samples with higher antibody levels. However, because the assay's cutoff is set at 15 U/mL, most sample clinical classifications would remain unchanged despite the bias.
The recalled product was distributed nationwide across the United States, including Arizona, New York, Louisiana, Florida, California, Texas, Iowa, Mississippi, Utah, and Illinois, with a total of 376 units affected. The source document does not specify a remedy or recommended action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL. Quantity: 376 units Lot/code info: Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.