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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Magnesium Reagent Cartridges Recalled for Falsely Low Test Results

Agency Publication Date: December 26, 2024
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Summary

Siemens Healthcare Diagnostics is recalling 13,115 units of Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges because they may produce falsely low magnesium measurements in patient samples. The error occurs intermittently, meaning standard laboratory quality control procedures may not detect that a patient's results are incorrect. This recall specifically affects cartridges with catalog number K3057 and Siemens Material Number 10445158.

Risk

Falsely low magnesium test results can lead to incorrect medical diagnoses or inappropriate patient treatments. While no injuries have been reported, inaccurate test data poses a risk to patient safety if medical decisions are based on the flawed results.

What You Should Do

  1. This recall affects Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (Catalog Number K3057, Siemens Material Number 10445158) from lots 24057BB and 24064BC.
  2. Stop using the recalled product immediately to prevent the reporting of inaccurate patient magnesium levels.
  3. Contact Siemens Healthcare Diagnostics or your medical laboratory distributor to arrange for the return, replacement, or correction of the affected cartridges.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Dimension Vista Total Magnesium (MG) Flex Reagent Cartridge (360 tests)
Model / REF:
K3057
10445158
Lot Numbers:
24057BB
24064BC
UDI:
00842768015694

Recall involves Siemens Material Number (SMN) 10445158 and Catalog Number K3057.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95751
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Sold By: Siemens Healthcare Diagnostics; Medical laboratory distributors
Manufactured In: United States
Units Affected: 13,115 units (11,520 US, 1,595 ROW)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.