Abbott Laboratories recalls ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP
Recalled Product
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.
Hazard / Issue
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Issued by
FDA
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