FDAFebruary 3, 2021device
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
What to do
FDA enforcement status: Ongoing
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
Recall history
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