Beckman Coulter Inc. — 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 Clinical Analyzer
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- August 4, 2025
Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom of Great Britain and Northern Ireland, Namibia, Turkey, Republic of Korea
What's affected?
- Product
- 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 Clinical Analyzer
- Brand
- Beckman Coulter Inc.
- Lot code
- REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Additional details
REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 116.
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