Quick Facts at a Glance
- Recall Date
- June 25, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beckman Coulter
- Product type
- Laboratory Diagnostics/ Microbiology Panel
- Model numbers
- Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 25, 2025
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions
About This Product
MicroScan Neg MIC 3J is a diagnostic panel used in microbiology testing to identify organisms and antibiotic susceptibilities.
Why This Is Dangerous
The missing drug in one well and doubled antibiotic content may alter test outcomes, potentially affecting patient treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate stop-use is required to mitigate potential incorrect test results and patient risk.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number C54814.
- Verify lot number 2025-08-23 on packaging.
- Confirm 20 panels per box and 688 total boxes.
Where to find product info
FDA recall page and Beckman Coulter customer support for instructions.
What timeline to expect
Refunds or replacements will be issued according to manufacturer guidance, typically within weeks pending processing.
If the manufacturer is unresponsive
- Document all inquiries in writing
- Escalate to regulatory authorities if the company is unresponsive
How to prevent similar issues
- Verify lot numbers before use
- Implement batch-traceability in lab workflows
- Maintain up-to-date supplier recalls database
Documentation advice
Keep recall notices, purchase records, and any correspondence with Beckman Coulter.
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Product Details
Catalog Number: C54814. UDI code: N/A. Lot Number: 2025-08-23. Quantity: 688 boxes (20 panels per box). Distribution: International, in Japan.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 20 panels per box
- International distribution in Japan
- High hazard level
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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