Autoimmune EIA Anti-Tissue Transglutaminase — Class II medical device recall Z-1800-2020
Completed recall by Bio-Rad Labs, reported 2020-05-06, distributed nationwide. An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compar
| Recall number | Z-1800-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Labs, Benicia, CA, United States |
| Recall initiated | 2019-04-03 |
| Classified | 2020-04-24 |
| Reported by FDA | 2020-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 376 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00847817018336 |
| Lot numbers | 18200A |
| Model numbers | 425-2260 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1800-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.