Siemens Healthcare Diagnostics, Inc. 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 urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plas Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

The firm, Siemens Healthineers, sent "URGENT MEDICAL DEVICE CORRECTION" (VC-22-01.A.US) on 01/28/2022 via Fed Ex to all customers to inform them of the issue and instruct them to discontinue use and discard the affected lots. Complete and return the Field Correction Effectiveness Check Form via email at uscctsfcaecfax.team@siemens-healthineers.com or fax to: (312) 275-7795. At the present time, Siemens has no replacement lots to offer customers. Siemens suggests using an alternate methodology for magnesium until a replacement lot is available. If you received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Remote Services Center or your local Siemens Technical Support Representative. Replacement kits will be provided when a new lot is available. If you have any questions, please contact your Siemens Healthineers Remote Services Center or your local Siemens Healthineers Technical Support Representative.