CanadaWhat's being recalled
Companies: Siemens Healthcare Diagnostics Inc., 500 Gbc Drive, Newark, Delaware, United States, 19714.
How to identify it
Affected products: EMIT® 2000 Quinidine Assay; Lot or serial number: 2597; Model or catalogue number: OSR4Q229
Affected products: EMIT® 2000 Quinidine Assay; Lot or serial number: 2709; Model or catalogue number: OSR4Q229
Affected products: EMIT® 2000 Quinidine Assay; Lot or serial number: 2627; Model or catalogue number: OSR4Q229
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)