FDA Device recall Z-1800-2020
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test
- FDA Device
- Class II
- completed
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test by Bio Rad Labs, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1800-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-04-03 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bio Rad Labs |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1800-2020%22
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