Euro Diagnostica AB recalls is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific fo…

Recall date

October 21, 2016

Source

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

Recall number

Z-2919-2018

FDA classification

Class III

Brand / firm

Euro Diagnostica AB

Sold / distributed

MN

Why it was recalled

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.