Euro Diagnostica AB recalls is a quantitative/qualitative enzyme-linked immunosorbent as
Recalled Product
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 anti-cardiolipin IgM 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.
Hazard / Issue
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Issued by
FDA
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