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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.: Atellica CH Reagents Recalled Due to Potential for Incorrect Magnesium Results

Agency Publication Date: August 29, 2023
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Summary

Siemens Healthcare Diagnostics is recalling several Atellica CH reagents used in laboratory testing, affecting approximately 38,630 units worldwide. The recall includes specific reagents for LDL Cholesterol Direct (DLDL), Total Protein II (TP), and two types of Triglycerides (Trig and Trig_2). These reagents may carry over during the testing process on the Atellica CH Analyzer, which can interfere with and cause inaccurate results for magnesium (Mg) levels. Consumers should contact their healthcare provider or the manufacturer for further instructions.

Risk

The defect causes 'reagent carryover,' where chemical residue from one test contaminates the next, leading to potentially inaccurate magnesium measurements. Incorrect magnesium results can lead to a misdiagnosis or inappropriate treatment for patients with electrolyte imbalances.

What You Should Do

  1. Identify if your laboratory or healthcare facility uses the Atellica CH Analyzer with any of the following reagents: LDL Cholesterol Direct (SMN 11097632), Total Protein II (SMN 11097604), Triglycerides (SMN 11097591), or Triglycerides_2 (SMN 11537222).
  2. Check your reagent packaging for the following Universal Device Identifier (UDI) numbers: 00630414596181, 00630414596372, 00630414596495, or 00630414610955. All lots of these specific products are affected.
  3. If you are a patient who recently had magnesium, cholesterol, protein, or triglyceride levels tested on an Atellica CH system, contact your healthcare provider to determine if your results were affected and if retesting is necessary.
  4. Healthcare facilities should contact Siemens Healthcare Diagnostics at their local service center or through their official website for technical guidance on mitigating reagent carryover.
  5. For more information or additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer mitigation and healthcare provider consultation

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

Affected Products

Product: Atellica CH LDL Cholesterol Direct (DLDL)
Model / REF:
SMN: 11097632
Recall #: Z-1268-2023
UPC Codes:
00630414596181
Lot Numbers:
All Lots
Product: Atellica CH Total Protein II
Model / REF:
SMN: 11097604
Recall #: Z-1269-2023
UPC Codes:
00630414596372
Lot Numbers:
All Lots
Product: Atellica CH Triglycerides (concentrated)
Model / REF:
SMN: 11097591
Recall #: Z-1270-2023
UPC Codes:
00630414596495
Lot Numbers:
All Lots
Product: Atellica CH Triglycerides_2
Model / REF:
SMN: 11537222
Recall #: Z-1271-2023
UPC Codes:
00630414610955
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91665
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Sold By: Siemens Healthcare Diagnostics; Medical supply distributors
Manufactured In: United States
Units Affected: 4 products (8420 units; 13071 units; 11824 units; 5315 units)
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.

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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.