Euro Diagnostica AB recalls Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test resu…

Recall date

February 14, 2017

Source

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

Recall number

Z-0306-2018

FDA classification

Class II

Brand / firm

Euro Diagnostica AB

Sold / distributed

MN, NE, TX

Why it was recalled

Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.

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

What was recalled

Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.