Abbott Laboratories recalls ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantita…

Recall date

April 18, 2017

Source

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

Recall number

Z-2613-2017

FDA classification

Class II

Brand / firm

Abbott Laboratories

Sold / distributed

Worldwide Distribution - USA (nationwide) and to the countries of : ARGENTINA, ARMENIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, CANADA, CHINA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEM. REP. OF THE CON, DENMARK, EG…

Why it was recalled

Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.

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 SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.