Device recall
Z-0822-2019: Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R)…
FDA device recall · Class III · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-0822-2019 |
|---|---|
| Recall event | 81890 |
| Product | Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially… |
| Product code | PAM |
| Recalling firm | Luminex Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 4, 2020 |
| 510(k) numbers | K122514 |
| FEI number | 3002524000 |
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