Product Wiki · Recalls · Health Canada — Medical Devices

xTAG Gastrointestinal Pathogen Panel (GPP) (2019-02-09) — recall 59054

Health Canada — Medical Devices · Canada · 2019-03-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59054
Date of alert
2019-03-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/xtag-gastrointestinal-pathogen

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