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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 epoc BGEM BUN Test Cards Recalled for Inaccurate Results

Agency Publication Date: April 29, 2026
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Summary

Siemens Healthcare Diagnostics Inc. is recalling approximately 71,725 epoc BGEM BUN Test Cards used with the epoc Blood Analysis System. The affected test cards may produce inaccurately low pH and Total Carbon Dioxide (mTCO2) readings in patient blood samples. This defect can lead healthcare providers to treat a patient for a condition they do not have (acidosis) or miss a diagnosis for a condition they do (alkalosis). Check the test card packaging for specific lot numbers distributed nationwide and in multiple countries.

Risk

Incorrectly low test results can cause doctors to provide unnecessary treatment for nonexistent respiratory or metabolic acidosis, or fail to treat actual alkalosis, potentially leading to serious patient harm from improper medical intervention.

What You Should Do

  1. Identify your product by checking the packaging for Siemens Material Number (SMN) 10736515 and UDI-DI 00809708121860.
  2. Check for lot numbers 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70, 02-26027-80, or 02-26028-80.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report a complaint.

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: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
Model / REF:
10736515
Lot Numbers:
01-26024-70
01-26026-70
01-26028-70
01-26030-70
02-26027-80
02-26028-80
UDI:
00809708121860

Lot numbers 01-26030-70 and 02-26028-80 distributed Outside US (OUS) only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98680
Status: Active
Manufacturer: Siemens Healthcare Diagnostics Inc
Sold By: Authorized distributors
Manufactured In: United States
Units Affected: 71,725
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.