Beckman Coulter, Inc. recalls MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dri…

Recall date

September 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1794-2026

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

International distribution to the country of Poland.

Why it was recalled

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.