Device 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 clinical findings.
Z-1800-2020
Product summary
- Firm
- Bio-Rad Labs
- Event
- Event 85074
- Status
- Completed
- Classification
- Class II
- Quantity
- 376 units
- Official record key
device-enforcement:Z-1800-2020
Official wording
Reason: 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.
Code information: Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.
Distribution pattern: US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.
Derived failure modes
-
Unknown
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.