medical Class III Updated 2018-08-29

Euro Diagnostica AB recalls is a qualitative indirect enzyme immunoassay enzyme-linked i

Recalled 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.


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 1740 (kit) and TS 1743 (PC)
View official government recall

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