Device recall
Z-0809-05: Nichols IRMA Intact PTH Assay, catalog No. 40-2171
FDA device recall · Class II · Nichols Institute Diagnostics
Key facts
| Recall number (Z-number) | Z-0809-05 |
|---|---|
| Recall event | 31493 |
| Product | Nichols IRMA Intact PTH Assay, catalog No. 40-2171 |
| Product code | CEW |
| Recalling firm | Nichols Institute Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 16, 2012 |
| 510(k) numbers | K861797 |
| FEI number | 2050095 |
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