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Euro Diagnostica AB recalls is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for
Recalled August 29, 2018 · FDA recall Z-2919-2018 · 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 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.
Manufacturer(s)
Euro Diagnostica AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →