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 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.
Hazard / Issue
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Issued by
FDA
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