Official recall notice

FDA DeviceClass IINotable

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

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: 15099590799250/ V5.03 Panel Update 11

Verify with the official notice →
Share:

Related Recalls

2026-08-26 · FDA_DEVICE
FDA Recall: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w
Beckman Coulter Inc.
2026-08-26 · FDA_DEVICE
FDA Recall: Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 50
Beckman Coulter Inc.
2026-08-12 · FDA_DEVICE
FDA Recall: REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following in
Beckman Coulter Inc.
2026-04-29 · FDA_DEVICE
FDA Recall: Access Total T4 Calibrator, Catalog No. 33805
Beckman Coulter, Inc.