Abbott Laboratories, Inc recalls The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay.…

Recall date

May 16, 2018

Source

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

Recall number

Z-1993-2019

FDA classification

Class II

Brand / firm

Abbott Laboratories, Inc

Sold / distributed

Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brun…

Why it was recalled

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

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

What was recalled

The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.