Abbott Laboratories, Inc recalls C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sa…

Recall date

May 16, 2018

Source

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

Recall number

Z-1992-2019

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

C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.