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FDAMay 24, 2019device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

UPCs

0038074001747700380740145262

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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