Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0767-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

Product Classification:

Class II

Date Initiated: November 12, 2024

Date Posted: January 1, 2025

Recall Number: Z-0767-2025

Event ID: 95751

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

Status: Ongoing

Product Quantity: 13,115 units (11,520 US, 1,595 ROW)

Code Information:

Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated