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🇨🇦 EMIT® 2000 Quinidine Assay

Recall date: October 15, 2026Country: CACategory: medical_devices
Hazard/Reason: Siemens Healthineers has confirmed through the investigation of customer complaints and internal investigation that the potential for Repeatability precision to be greater than 10% coefficient of variation (CV) and Within-Lab precision to be greater than 15% CV. Using a 20 - day ANOVA study, Repeatability ranged from 3.09% to 52.03% CV across the assay range when using multiple lots of reagents on the DXC 700 AU and the Viva-ProE. In the same study, Within-Lab precision ranged from 7.72% to 53.39% CV across the assay range.
This page links to official sources. Verify model/lot/batch details in the official notice.