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

This recall has been terminated (originally issued August 23, 2018).

Company

Euro Diagnostica Ab

Recall Initiated

October 21, 2016

Posted

August 23, 2018

Terminated

November 5, 2019

Recall Number

Z-2920-2018

Quantity

6

Firm Location

Malmo Sweden

Official Source

View on FDA website ↗