Official recall record

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clin

What the authority reported

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

• 2026-07-15 · US FDA — Medical Devices
  Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, D
• 2026-09-02 · US FDA — Medical Devices
  DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, Dx

Other recalls from this brand

• 2026-09-02 · US FDA — Medical Devices
  DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU
• 2026-09-02 · US FDA — Medical Devices
  DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
• 2026-07-15 · US FDA — Medical Devices
  Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Modul

All 32 official recall notices naming Beckman Coulter, Inc. on this site →