Beckman Coulter, Inc.: MicroScan Neg MIC 3J REF C54814
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Beckman Coulter, Inc.
- Product
- MicroScan Neg MIC 3J REF C54814
- Reason / hazard
- Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- International distribution in the country of Japan.
- Recall initiated
- 2025-06-25
- Code info
- Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
- Product quantity
- 688 boxes (20 panels per box)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- West Sacramento
- State
- CA
- Country
- United States
- Event id
- 98553
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