Recall Z-2922-2018 ยท LKJ Antinuclear Antibody, Antigen, Control
Euro Diagnostica AB
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.
| 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 | 4 |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912291 | DISTAT ANTI-SCL-70 KIT Shield Diagnostics, Ltd., Jul 30, 1991 |