Device recall
Z-0648-2013: Immunoradiometric assay. Device is an immunoradiometric assay designed for the…
FDA device recall · Class III · Siemens Healthcare Diagnostics
Key facts
| Recall number (Z-number) | Z-0648-2013 |
|---|---|
| Recall event | 63852 |
| Product | Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status. |
| Product code | JLW |
| Recalling firm | Siemens Healthcare Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 28, 2013 |
| 510(k) numbers | K872305 |
| FEI number | 2432235 |
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