HIGH

MicroScan Neg MIC 3J REF C54814

Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

Quick Facts at a Glance

Recall Date
June 25, 2025
Hazard Level
HIGH
Brand
Beckman Coulter

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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Full Description

MicroScan Neg MIC 3J REF C54814. Reason: Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics. Classification: Class II. Quantity: 688 boxes (20 panels per box). Distribution: International distribution in the country of Japan.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
Report Date
April 15, 2026
Recall Status
ACTIVE

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