Recall Z-2918-2018 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Euro Diagnostica AB
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
| Date | Aug 23, 2018 (initiated Feb 14, 2016) |
| Status | Terminated |
| Reason | Decreasing performance overtime. |
| Root cause | Nonconforming Material/Component |
| Action | None |
| Quantity | 25 kits (US only) |
| Distribution | Minnesota and Texas Foreign: Iran |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091657 | IMMUNOSCAN CCPLUS Euro-Diagnostica AB, Nov 19, 2009 |