Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

• CFN — Immunology1 device
• JGS — Clinical Chemistry1 device

• Z-1233-2025 — DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.Class II·Ongoing·2025-01-10

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K221114 — Immunoglobulin G (IgG)Code CFN·2023-08-02
• K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerCode JGS·2023-07-20