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Euro Diagnostica AB recalls is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies
Recalled August 29, 2018 · FDA recall Z-2920-2018 · Euro Diagnostica AB
Hazard
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. · FDA Class III
Units
6
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 IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG 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
Manufacturer(s)
Euro Diagnostica AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →