Recall Z-2919-2018 ยท LKO Anti-Rnp Antibody, Antigen And Control
Euro Diagnostica AB
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 Sjgren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a mul
| 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
| K905194 | DIASTAT ANTI-RO (SS-A) Shield Diagnostics, Ltd., Dec 13, 1990 |