Abbott Laboratories recalls ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem…

Recall date

May 24, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2078-2019

FDA classification

Class III

Brand / firm

Abbott Laboratories

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed worldwide to ALGERIA, ANDORRA, AUSTRIA,…

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.