Product Wiki · Recalls · Health Canada — Medical Devices

XN-10 and X-11 Modules (2017-04-04) — recall 56838

Health Canada — Medical Devices · Canada · 2017-05-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56838
Date of alert
2017-05-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The protective plastic sheet that is intended to cover and protect electronic components inside the XN-series analyzers was not positioned correctly during manufacturing. Reagent from a leaking valve created a build-up of salt on an electronic component because of the misalignment of the protective sheet. The salt build-up created a salt bridge that allowed current to continue to flow, create heat, and eventually ignite adjacent resin parts inside the analyzer.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/xn-10-and-x-11-modules-2017-04

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