FDAJanuary 28, 2022device
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and ur...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.
What to do
FDA enforcement status: Ongoing
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
Recall history
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