Official recall notice

FDA DeviceClass IINotable

FDA Recall: REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following in

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

Hazard

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

Product description

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

Affected products

UDI: 15099590799243/ V5.03 Panel Update 11

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