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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 Healthcare Diagnostics Inc: epoc BGEM Test Cards Recalled for Potentially Inaccurate High Glucose Results

Agency Publication Date: August 28, 2023
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Summary

Siemens Healthcare Diagnostics Inc is recalling approximately 4,022 epoc BGEM Test Cards (BUN, Crea, and Veterinary models) because they may provide inaccurately high glucose readings for samples that are actually at the low end of the testing range. This recall affects cards used with epoc Host software version 3.37.3, epoc NXS software version 4.10.6, and Sensor Configuration 41.1. If a patient or animal actually has low blood sugar but the test incorrectly shows a high result, it could lead to dangerous treatment decisions or a failure to provide necessary medical care. These products were distributed to various medical facilities and veterinary clinics across several states and international locations between May and August 2023.

Risk

The defect causes the test card to report a high glucose level when the actual level is low. This discrepancy can lead to a missed diagnosis of hypoglycemia (dangerously low blood sugar) or cause medical providers to administer unnecessary glucose-lowering treatments, which can result in serious health complications.

What You Should Do

  1. Check your medical or veterinary facility's inventory for epoc BGEM Test Cards with the following Siemens Material Numbers: 10736515 (BUN), 10736382 (Crea), or 10736516 (Veterinary).
  2. If you have the BUN Test Card (Material 10736515), identify if you have affected lot numbers: 04-23003-60 (expiry 20-Jun-2023), 11-22337-60 (expiry 20-May-2023), 04-23034-40 (expiry 21-Jul-2023), 04-23059-50 (expiry 15-Aug-2023), 04-23059-60 (expiry 15-Aug-2023), or 04-23069-40 (expiry 25-Aug-2023).
  3. If you have the Crea Test Card (Material 10736382), check for lot numbers: 03-23002-60 (expiry 19-Jun-2023) or 03-23056-50 (expiry 12-Aug-2023).
  4. If you have the Veterinary BUN & TCO2 Test Card (Material 10736516), check for lot number: 04-23043-51 (expiry 30-Jul-2023).
  5. If you have an affected product, contact your healthcare provider or Siemens Healthcare Diagnostics Inc at 1-888-463-6332 for further instructions on how to handle the discrepant results and potential replacement cards.
  6. Contact the FDA’s medical device recall hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional safety information.

Your Remedy Options

📋Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: epoc BGEM BUN Test Card
Model / REF:
Material Number: 10736515
Sensor Configuration 41.1
UPC Codes:
00809708121860
Lot Numbers:
04-23003-60 (expiry 20-Jun-2023)
11-22337-60 (expiry 20-May-2023)
04-23034-40 (expiry 21-Jul-2023)
04-23059-50 (expiry 15-Aug-2023)
04-23059-60 (expiry 15-Aug-2023)
04-23069-40 (expiry 25-Aug-2023)
Date Ranges: May 2023 - August 2023
Product: epoc BGEM Crea Test Card
Model / REF:
Material Number: 10736382
Sensor Configuration 41.1
UPC Codes:
00809708072254
Lot Numbers:
03-23002-60 (expiry 19-Jun-2023)
03-23056-50 (expiry 12-Aug-2023)
Date Ranges: June 2023 - August 2023
Product: epoc BGEM Test Card (BUN & TCO2), Veterinary
Model / REF:
Material Number: 10736516
Sensor Configuration 41.1
UPC Codes:
00630414243788
Lot Numbers:
04-23043-51 (expiry 30-Jul-2023)
Date Ranges: July 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92537
Status: Active
Manufacturer: Siemens Healthcare Diagnostics Inc
Sold By: Specialty medical distributors; Siemens Healthcare direct sales
Manufactured In: United States
Units Affected: 3 products (3201 ea; 473 ea; 348 ea)
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New York, Ohio, Oklahoma, South Carolina, South Dakota, Texas

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 · 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.