Fresh Recalls

Beckman Coulter recalls

7 recent recalls on record for Beckman Coulter in connected official government data as of October 22, 2026 at 12:00 PM UTC.

Models with recalls

Access Total T4 Calibrator (1)Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1 (1)Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1 (1)DxC 500 AU Clinical Chemistry Analyzers (1)DxC 500i Clinical Analyzer Modules (1)REF # D23352 (1)REF # D23354 (1)

All Beckman Coulter recalls

FDA Class II · Medical device · October 14, 2026

DxC 500 AU Clinical Chemistry Analyzers recall — Beckman Coulter Inc.

Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to us…

Official ID Z-0084-2027 · Official record ↗

FDA Class II · Medical device · October 14, 2026

DxC 500i Clinical Analyzer Modules recall — Beckman Coulter Inc.

Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use …

Official ID Z-0083-2027 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1 recall — Beckman Coulter Inc.

a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of …

Official ID Z-2974-2026 · Official record ↗

FDA Class II · Medical device · August 26, 2026

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1 recall — Beckman Coulter Inc.

a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of …

Official ID Z-2973-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

REF # D23354 recall — Beckman Coulter Inc.

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

Official ID Z-2889-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

REF # D23352 recall — Beckman Coulter Inc.

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

Official ID Z-2888-2026 · Official record ↗

FDA Class II · Medical device · April 29, 2026

Access Total T4 Calibrator recall — Beckman Coulter, Inc.

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A fal…

Official ID Z-1922-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.