Drug recall
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of…
FDA recall event 82745 · Class II · Luminex Molecular Diagnostics
Key facts
| Event ID | 82745 |
|---|---|
| Recall numbers | Z-1767-2019 |
| Recalling firm | Luminex Molecular Diagnostics |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reports have been received of lower MS2 MFI values when using the panel. |
| Initiation date | Feb 22, 2019 |
| Report date | Jun 19, 2019 |
| City | Toronto |
| Country | Canada |
| FEI number | 3002777243 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: