FDAHealthSeptember 8, 2025
Beckman Coulter, Inc. — 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 Neg
⚠️ Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- September 8, 2025
International distribution to the country of Poland.
What's affected?
- 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.
- Lot code
- 2026-05-08
Additional details
Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3 boxes.
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