Device recall
Z-0328-2016: CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product…
FDA device recall · Class III · Biochemical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0328-2016 |
|---|---|
| Recall event | 72197 |
| Product | CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices. |
| Product code | JJX |
| Recalling firm | Biochemical Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 26, 2016 |
| 510(k) numbers | K050328 |
| FEI number | 2432495 |
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