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 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

Affected States: MN
Lot/Code Info: Lot #'s: TS2725 (kit) and TS 2733 (PC)
View official government recall

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