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Simplexa Covid-19 Direct — recall 72669

Health Canada — Medical Devices · Canada · 2023-02-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
72669
Date of alert
2023-02-09
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Microbiology
Product type
Medical devices
Reported risk: Customer complaints were received for disc leaks while running Simplexa Covid-19 Direct kit with assay definition version 2 (high spin & temp). Leakage was confirmed by retain testing on 1/6/22 with discs run on Covid-19 Direct assay definition version 2. No disc leakage occurred with version 3 (reduced spin & temp). Simplexa Flu A/B & RSV (mol2655) and Simplexa Covid-19 & Flu A/B Direct (mol4250) have similar assay definitions and are also at risk for leakage. Recall start date: February 01, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/simplexa-covid-19-direct

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