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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

Dimension Creatinine Flex Reagent Cartridges Recalled for Inaccurate Results

Agency Publication Date: April 28, 2026
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Summary

Siemens Healthcare Diagnostics is recalling 18,080 units of Dimension Creatinine Flex reagent cartridges (model DF33B). These cartridges, used in laboratory settings to measure creatinine levels, may produce inaccurate results that are either too high or too low. No injuries or incidents have been reported, but the defect could lead to incorrect medical assessments.

Risk

The quality control and patient sample results may be imprecise, leading to erroneously increased or decreased creatinine values. This inaccuracy could potentially result in misdiagnosis or delayed treatment for conditions related to kidney function.

What You Should Do

  1. Identify if your laboratory has Dimension Creatinine Flex reagent cartridges with material number 10872079 and lot numbers GA6307 or BA7005.
  2. Check the packaging for the following Unique Device Identifiers (UDI): (01)00630414595009(10)GA6307(17)20261103 or (01)00630414595009(10)BA7005(17)20270105.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, Siemens Healthcare Diagnostics, or your distributor to arrange for a return, replacement, or correction of the affected lots.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

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 Creatinine Flex reagent cartridge
Model / REF:
DF33B
Lot Numbers:
GA6307
BA7005
UDI:
00630414595009

Material Number: 10872079

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98666
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Sold By: Siemens Healthcare Diagnostics; Laboratory supply distributors
Manufactured In: United States
Units Affected: 18,080
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.