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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

MicroScan Neg MIC 3J Diagnostic Panels Recalled for Dosing Error

Agency Publication Date: April 3, 2026
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Summary

Beckman Coulter, Inc. is recalling 688 boxes of MicroScan Neg MIC 3J diagnostic panels (REF C54814) due to a manufacturing defect. The affected panels are missing a drug in one specific well (well 4/4) while containing double the intended amount of antibiotics in others. Each box contains 20 panels and was manufactured in the United States and distributed to Japan.

Risk

The incorrect dosage of antibiotics on the diagnostic panel can lead to inaccurate laboratory results, potentially causing healthcare providers to prescribe incorrect or ineffective antibiotic treatments for patients with infections. No injuries or incidents have been reported to date.

What You Should Do

  1. Identify if you have the affected product by checking the packaging for Catalog Number C54814 and Lot Number 2025-08-23.
  2. Stop using the recalled product immediately.
  3. Contact the manufacturer, Beckman Coulter, Inc., or your authorized distributor to arrange for the return, replacement, or correction of the panels.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions 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: MicroScan Neg MIC 3J (20 panels per box)
Model / REF:
C54814
Lot Numbers:
2025-08-23

REF C54814; 688 boxes affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98553
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: International distribution; Authorized distributors in Japan
Manufactured In: United States
Units Affected: 688 boxes (20 panels per box)
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.