EMIT® 2000 Quinidine Assay
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
EMIT® 2000 Quinidine Assay |
2597 |
OSR4Q229 |
EMIT® 2000 Quinidine Assay |
2709 |
OSR4Q229 |
EMIT® 2000 Quinidine Assay |
2627 |
OSR4Q229 |
Issue
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.
Additional information
Details
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive, Newark, Delaware, United States, 19714
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