Beckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules because a software issue can cause test units to revert to defaults without warning, potentially resulting in falsely elevated reported results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to a software defect that can cause falsely elevated reported results without user notification. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Beckman Coulter Inc. is recalling specific DxC 500i Clinical Analyzer Modules, including the DxC 500 AU Module w/ISE (Part No. C63522), DxC 500 AU Module (Part No. C63521), and Access 2 Module (Part No. C13252). The affected units are running software version 1.3.5 or earlier. The recall covers 146 units in the United States and 170 units outside the United States, with nationwide distribution in the US.
The recall is due to a software issue that affects the analyzers when testing plasma samples. If a user configures a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration may cause the analyzer to revert the test units to the system default setting. The system does not provide a warning or notification to alert the user that the configured units have reverted. This issue can result in falsely elevated reported results.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users should contact Beckman Coulter for instructions on how to address the software issue.
The recalled product
- Product
- DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
- Manufacturer
- Beckman Coulter Inc.
Distribution
Distributed nationwide across the United States.
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