medical Class III Updated 2018-08-29

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

Affected States: MN
Lot/Code Info: Lot #'s: TS 2819 (kit) and TS 2841 (PC)
View official government recall

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