Beckman Coulter is recalling approximately 7,729 UniCel Dxl 600 and UniCel Dxl 800 immunoassay analyzers because a communication defect may prevent the systems from restarting after a standard shutdown. If this issue occurs, the instrument will fail to initialize and enter its ready mode, meaning it cannot process patient samples, quality controls, or calibrators. This failure results in significant delays for critical medical test results, including Troponin tests used in cardiac evaluations.
The defect prevents the analyzer from functioning, which delays the delivery of diagnostic results to healthcare providers. In clinical settings, a delay in obtaining critical lab data like Troponin levels can postpone life-saving treatment or medical interventions.
1,272 units affected.
6,457 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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