Official recall record

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

US FDA — Medical Devices · 2025-01-10 · ChinaClass II

Issuing authority: US FDA — Medical Devices
Alert date: 2025-01-10
Country of alert: China
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 14987666545058
Brand on record: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Product category: Medical Device

What the authority reported

Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

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.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · China · all filters

Same barcode in other registries

The same EAN appears in 4 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2025-03-17 · US FDA — Medical Devices
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065
2025-03-20 · US FDA — Medical Devices
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065.
2026-07-15 · US FDA — Medical Devices
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Numbe
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

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