FDA DeviceClass IINotable

FDA Recall: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: -

Date: 2026-08-12
Brand: Beckman Coulter Inc.
Category: Medical Device
FDA Class: Class II

Description

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Hazard

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

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