Medical Device Recall: Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Siemens Healthcare Diagnostics, Inc. · November 12, 2024
Reason for Recall
Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.
States Affected
NATIONWIDE
Quantity Affected
13,115 units (11,520 US, 1,595 ROW)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0767-2025
Status: ongoing
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