Beckman Coulter, Inc.: Panels, Test, Susceptibility, Antimicrobial
- Recalling firm
- 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
- Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-09-08
- Status
- Open, Classified
- Distribution
- International distribution to the country of Poland.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c683c384-3e63-47fd-b35d-9260c8819412