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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

Synchron Systems Direct LDL Cholesterol Reagent Recalled for False High Results

Agency Publication Date: November 6, 2025
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Summary

Beckman Coulter Inc. is recalling 2,932 units of Synchron Systems Direct LDL Cholesterol (LDLD) Reagent (REF: 969706). This specific lot of reagent has an increased probability of generating false high LDL cholesterol results, which was discovered during internal testing. These incorrect results could lead to a misdiagnosis or inappropriate medical treatment for patients monitoring their cholesterol levels.

Risk

False high cholesterol readings may cause a healthcare provider to prescribe unnecessary medications or adjust treatment plans based on inaccurate data. No patient injuries or incidents have been reported to date.

What You Should Do

  1. This recall affects Synchron Systems Direct LDL Cholesterol (LDLD) Reagents with catalog number (REF) 969706 and lot number M404166.
  2. Identify the affected product by checking the label for lot number M404166 and an expiration date of November 30, 2025.
  3. Stop using the recalled product immediately.
  4. Contact Beckman Coulter Inc. or your distributor to arrange for a return, replacement, or correction of the affected reagents.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or concerns 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: SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent (REF 969706)
Model / REF:
969706
Lot Numbers:
M404166 (Exp 30Nov2025)

The issue was discovered internally and confirmed on August 19, 2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97628
Status: Active
Manufacturer: Beckman Coulter Inc.
Sold By: Clinical laboratories; Healthcare facilities; Authorized distributors
Manufactured In: United States
Units Affected: 2,932 units
Distributed To: Alabama, Arkansas, California, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Washington, West Virginia

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.