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Euro Diagnostica AB recalls is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum
Recalled August 29, 2018 · FDA recall Z-2922-2018 · Euro Diagnostica AB
Hazard
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. · FDA Class III
Units
4
Sold at
MN
Description
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
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.
Manufacturer(s)
Euro Diagnostica AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →