Beckman Coulter, Inc.: Panels, Test, Susceptibility, Antimicrobial
Recall Summary Beckman Coulter is recalling MicroScan Neg MIC 3J test panels (REF C54814) distributed in Japan due to a manufacturing defect where well 4/4 is missing a drug and contains double the normal amount of antibiotics in other wells. This is a Class II recall affecting antimicrobial susceptibility test panels used to determine antibiotic effectiveness against bacteria.
- Recalling firm
- Beckman Coulter, Inc.
- Product
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-06-25
- Status
- Open, Classified
- Distribution
- International distribution in the country of Japan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a6bdcd3f-564d-4855-8b9c-b0ae645cc05e