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.
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
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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MicroScan Neg MIC 3J is a diagnostic panel used in microbiology testing to identify organisms and antibiotic susceptibilities.
The missing drug in one well and doubled antibiotic content may alter test outcomes, potentially affecting patient treatment decisions.
This recall is not part of a broader industry pattern.
Immediate stop-use is required to mitigate potential incorrect test results and patient risk.
FDA recall page and Beckman Coulter customer support for instructions.
Refunds or replacements will be issued according to manufacturer guidance, typically within weeks pending processing.
Keep recall notices, purchase records, and any correspondence with Beckman Coulter.
Catalog Number: C54814. UDI code: N/A. Lot Number: 2025-08-23. Quantity: 688 boxes (20 panels per box). Distribution: International, in Japan.
No injuries or incidents have been reported.
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