Device recall
Z-1672-2020: The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative…
FDA device recall · Class II · Qualigen Inc
Key facts
| Recall number (Z-number) | Z-1672-2020 |
|---|---|
| Recall event | 85134 |
| Product | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for… |
| Product code | CDZ |
| Recalling firm | Qualigen Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2020 |
| 510(k) numbers | K182521 |
| FEI number | 3003355251 |
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