Device recall
Z-2381-2021: EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
FDA device recall · Class II · Thera Test Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2381-2021 |
|---|---|
| Recall event | 88477 |
| Product | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 |
| Product code | QKO |
| Recalling firm | Thera Test Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2022 |
| FEI number | 1421346 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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