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

Recall date

October 21, 2016

Source

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

Recall number

Z-2920-2018

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 IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders