xTAG Gastrointestinal Pathogen Panel (GPP) (2019-02-09)
- Starting date:
- February 9, 2019
- Posting date:
- March 1, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69194
Affected Products
xTAG Gastrointestinal Pathogen Panel (GPP)
Reason
Luminex received customer complaints regarding xTAG Gastrointestinal Pathogen Panel (GPP) reporting lower MS2 MFI values. Investigational testing has determined that this is due to the variability of conductivity found in a lot of xTAG GPP Reporter Buffer, a component of the xTAG Gastrointestinal Pathogen Panel (GPP) kit. The potential impact of xTAG GPP Reporter Buffer with low conductivity on the xTAG GPP assay is that when testing patient specimens near the limit of detection (LoD) the assay has a remote possibility to generate false negative calls.
Affected products
xTAG Gastrointestinal Pathogen Panel (GPP)
Lot or serial number
IK032C-2031
IK032C-2032
IK032C-2033
IK032C-2034
IK032C-2035
IK032C-2036
IK032C-2037
Model or catalog number
I032C0415
Companies
- Manufacturer
-
Luminex Molecular Diagnostics, Inc.
439 University Avenue
Toronto
M5G 1Y8
Ontario
CANADA