What is the recall number and which product is affected?

The recall concerns Beckman Coulter MicroScan Neg MIC 3J REF C54814, 688 boxes (20 panels per box), lot 2025-08-23 distributed internationally in Japan.

What should I do if I own this product?

Stop using the product immediately. Follow the manufacturer's recall instructions and contact Beckman Coulter or your healthcare provider for guidance on refunds or replacements.

Are there any injuries reported?

No injuries or incidents have been reported to date.

Where can I find more recall details?

See the FDA enforcement page linked in the recall notice.

How will refunds or replacements be handled?

The manufacturer will provide specific instructions on refunds or replacements.

What is the exact hazard?

A manufacturing issue results in a missing drug in well 4/4 while containing double the amount of antibiotics, potentially impacting test results.

What is the distribution scope?

International distribution with focus in Japan as per data.

How do I identify the affected lot?

Check lot number 2025-08-23 on the product packaging.

Who should I contact for help?

Beckman Coulter or your healthcare provider for recall guidance.

When was the recall announced?

Recall date is 2025-06-25; report date 2026-04-15.

HIGHJune 25, 2025

Beckman Coulter MicroScan Neg MIC 3J REF C54814 Recall for Missing Drug in Well 4/4 and Antibiotic D

Beckman Coulter recalled 688 boxes of MicroScan Neg MIC 3J REF C54814 distributed in Japan. The issue: one well missing a drug while containing double the antibiotic amount. Patients and healthcare providers should stop using this device immediately and follow manufacturer instructions.

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

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

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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.

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

688 boxes recalled
20 panels per box
Catalog C54814
Lot 2025-08-23
International distribution in Japan
High hazard level

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTPETSINFANTSCHILDREN

Injury Types

POISONINGELECTRICALOTHERLACERATION

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeLaboratory Diagnostics/ Microbiology Panel

Product Details

Brand

Beckman Coulter

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