Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
Beckman Coulter identified a manufacturing defect in certain MicroScan Neg MIC 3J antibiotic susceptibility test panels (Catalog C54814, Lot 2025-08-23). Some panels are missing a drug in one well and contain double the amount of antibiotics in others, which could produce inaccurate test results. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls
What to do
- Stop using MicroScan Neg MIC 3J panels with Catalog Number C54814 and Lot Number 2025-08-23
- Contact Beckman Coulter for instructions on return or disposal
- Review any patient test results from affected panels with your laboratory director
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- MicroScan Neg MIC 3J REF C54814
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 688 boxes (20 panels per box)
- Illnesses reported
- None reported
- Manufactured in
- 2040 Enterprise Blvd, West Sacramento, CA, United States
- Classification
- Class II
- Recall number
- Z-1772-2026
In the FDA's words
- Description
- 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 Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23 Distribution: International distribution in the country of Japan. Affected quantity: 688 boxes (20 panels per box)
- Hazard
- Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
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