Beckman Coulter, Inc.: MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative
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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 Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- Reason / hazard
- Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- International distribution to the country of Poland.
- Recall initiated
- 2025-09-08
- Code info
- Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
- Product quantity
- 3 boxes
- Voluntary mandated
- Voluntary: Firm initiated
- City
- West Sacramento
- State
- CA
- Country
- United States
- Event id
- 98562
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