RX Modena Clinical Chemistry Analyzer Recalled for Incorrect Rerun Results
Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. This is a risk-of-harm product—a clinical analyzer with potential for incorrect patient test results that could affect medical decision-making—but without yet-reported adverse health consequences. Meets the rubric criterion for High severity.
Plain-English summary
Randox Laboratories Ltd. is recalling the RX Modena-IVD Clinical Chemistry Analyser (Catalog Number RX9000) distributed nationwide, including Puerto Rico. The analyzer is a clinical laboratory device used for automated chemical analysis of patient samples.
The FDA identified an issue with the analyzer's parameter re-run settings. Specifically, the settings for sample volume (low/high) and dilutions used for automatic re-runs do not meet the correct re-run conditions when samples fall above or below the assay range. This malfunction can prevent the re-run feature from working correctly and may result in incorrect test reporting.
Laboratories using this device should contact Randox Laboratories Ltd. regarding corrective actions. Users should verify the accuracy of recent test results and consult with the manufacturer about necessary steps to ensure reliable testing moving forward.
The recalled product
- Product
- RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- operational-failure
- incorrect-test-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 05055273214963 Lot/Batch Number:
Distribution
Distributed nationwide across the United States.
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