Recall Z-2920-2018 ยท MID System, Test, Anticardiolipin Immunological
Euro Diagnostica AB
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
| Date | Aug 23, 2018 (initiated Oct 21, 2016) |
| Status | Terminated |
| Reason | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| Root cause | Error in labeling |
| Action | none |
| Quantity | 6 |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001574 | DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 Axis-Shield, Jun 9, 2000 |