Device recall
Z-0214-2022: T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only…
FDA device recall · Class II · BioCheck, Inc.
Key facts
| Recall number (Z-number) | Z-0214-2022 |
|---|---|
| Recall event | 88869 |
| Product | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. |
| Product code | KLI |
| Recalling firm | BioCheck, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 14, 2025 |
| 510(k) numbers | K991432 |
| FEI number | 3002564473 |
At a glance
- 1–9 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