[Recalled] 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 I
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Luminex Molecular Diagnostics |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1767-2019 |
| Country of notice | Canada |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 February 2019 |
| EAN / barcode | 00840487100493 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Reports have been received of lower MS2 MFI values when using the panel.
This Class II recall concerns device products distributed in Canada and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.