Beckman Coulter, Inc. is recalling 2,109,804 units of its Access hsTnI Reagent, a specialized laboratory test used in hospitals and clinics to measure heart-related proteins. The recall was issued because samples containing extremely high levels of troponin can contaminate the testing machine's probe if the system does not wash it sufficiently. This contamination can cause the next patient's blood sample to show a falsely high result, even if their actual protein levels are normal.
A falsely elevated test result could lead doctors to misdiagnose a heart condition, potentially resulting in unnecessary medical procedures like heart imaging or invasive diagnostic catheterization. While no injuries have been reported, the carryover of protein from one sample to the next can interfere with critical medical decision points.
Quantity affected: 2,109,804 units. Used for quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
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Sources: FDA iRES · Raw API Response
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