Immunoassay Analyzer Calibration Failures May Produce Erroneous Test Results
DxI 9000 immunoassay analyzer may produce calibration failures where curves incorrectly switch from passed to failed, resulting in erroneous test results. Results may be misinterpreted by laboratory information systems.
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 device with risk of patient harm through erroneous diagnostic test results caused by calibration failures. No reported illnesses or injuries documented.
Plain-English summary
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137, a clinical laboratory diagnostic device used to perform immunoassay tests. Approximately 67 units are distributed in the United States and 178 units internationally across multiple countries.
The analyzer has a calibration system issue where calibration curves may switch from passed status to failed status due to system errors during sample aspiration. When this occurs, the analyzer may produce erroneous test results that may go unnoticed by laboratory staff or be misinterpreted by laboratory information systems.
Healthcare facilities and laboratories using affected units should contact Beckman Coulter immediately to verify whether they have a recalled device. Affected units are identified by UDI-DI 15099590732103 and specific serial numbers listed in the recall notice. Users should follow manufacturer instructions for corrective action.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer C11137
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- calibration-failure
- erroneous-results
- test-misinterpretation
Distribution
Distributed nationwide across the United States.
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