FDAMay 24, 2019device

ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.

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

0038074001746000380740145255

Recall history

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

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