Medical Device Recall: 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
Beckman Coulter, Inc. · September 8, 2025
Reason for Recall
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Product Description
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.
Distribution
International distribution to the country of Poland.
Quantity Affected
3 boxes
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1794-2026
Status: ongoing
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