Euro Diagnostica AB: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Agency Publication Date: August 23, 2018

Affected Products

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.

Lot #'s: TS2725 (kit) and TS 2733 (PC)

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 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

Lot #'s: TS 2783 (kit) and TS 2787 (PC)

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.

Lot #'s: TS 2819 (kit) and TS 2841 (PC)

Product: is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Lot #'s: TS 1740 (kit) and TS 1743 (PC)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80684

Status: Resolved

Manufacturer: Euro Diagnostica AB

Manufactured In: Sweden

Units Affected: 4 products (4; 6; 6; 4)

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Sources: FDA iRES · Raw API Response

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