Abbott Gmbh & Co. KG recalls ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative…

Recall date

December 14, 2017

Source

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

Recall number

Z-1629-2018

FDA classification

Class II

Brand / firm

Abbott Gmbh & Co. KG

Sold / distributed

Worldwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VT, WA, WY. Distributed internationally to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Barbados, Belarus, Belgium, Bos…

Why it was recalled

Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.