The FDA announced on June 26, 2026, that Beckman Coulter Inc. is recalling REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), installed on 158 instruments nationwide due to incorrect algorithms that may affect antimicrobial susceptibility test results.
How to tell if you have it
- REF # D23352
- MicroScan LabPro V5.03 Panel Update 11 (US)
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instrument
- B1018-284 MicroScan WalkAway-96 plus Instrument
- B1018-440 DxM-1040 MicroScan WalkAway Instrument
- B1018-496 DxM-1096 MicroScan WalkAway Instrument
The hazard
According to the FDA, the analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026), Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (March 16, 2026), and Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (December 23, 2025). Other recent recalls of similar products include Beckman Coulter REMISOL Advance Software Issue: Incorrect Test Results Results (April 29, 2026), Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk (January 30, 2026), and Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (January 5, 2026).