Device recall
Z-0547-2014: FastPack Total PSA Immunoassay Chemilunescence assay for the determination of…
FDA device recall · Class II · Qualigen Inc
Key facts
| Recall number (Z-number) | Z-0547-2014 |
|---|---|
| Recall event | 66842 |
| Product | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of… |
| Product code | LTJ |
| Recalling firm | Qualigen Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2014 |
| 510(k) numbers | K994419 |
| 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