Device recall
Z-1767-2019: xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative…
FDA device recall · Class II · Luminex Molecular Diagnostics
Key facts
| Recall number (Z-number) | Z-1767-2019 |
|---|---|
| Recall event | 82745 |
| Product | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316. |
| Product code | PCH |
| Recalling firm | Luminex Molecular Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K140377 |
| FEI number | 3002777243 |
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