FDASeptember 30, 2015device

Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.

What to do

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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