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/A Direct (mol4250) have similar assay definitions and are also at risk for leakage. Recall start date: February 01, 2023
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