Health product recall

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