Device recall
Z-3112-2017: Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog…
FDA device recall · Class II · Qualigen Inc
Key facts
| Recall number (Z-number) | Z-3112-2017 |
|---|---|
| Recall event | 77726 |
| Product | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit |
| Product code | MRG |
| Recalling firm | Qualigen Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2018 |
| 510(k) numbers | K123983 |
| 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