Medical device recalls Moderate risk

Beckman Coulter, Inc. recalls MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimi…

Recall date
July 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1609-2026
FDA classification
Class II
Brand / firm
Beckman Coulter, Inc.
Sold / distributed
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.

Why it was recalled

Due to the likely presence of contamination in well(s).

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 MIC 56 REF C42464 UDI-DI code: 15099590731212 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.

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