Beckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers due to a software issue that may 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 issue that may 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 DxC 500 AU Clinical Chemistry Analyzers, including models with and without ISE (Part Nos. C63519 and C63520), due to a software issue affecting the testing of plasma samples. The affected units are running software version 1.4.5 or earlier.
The software issue occurs when 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 in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. 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 recall involves 146 units in the US and 170 units outside the US, with worldwide distribution. The source text does not report any illnesses, injuries, or deaths associated with this software issue.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
- Manufacturer
- Beckman Coulter Inc.
Distribution
Distributed nationwide across the United States.
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