Device recall
Z-1800-2020: Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number…
FDA device recall · Class II · Bio-Rad Labs
Key facts
| Recall number (Z-number) | Z-1800-2020 |
|---|---|
| Recall event | 85074 |
| 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. |
| Product code | MVM |
| Recalling firm | Bio-Rad Labs |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K042644 |
| FEI number | 1000135116 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database