Device product
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.
Z-2918-2018
Product summary
- Event
- Event 80689
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 kits (US only)
- Official record key
device-enforcement:Z-2918-2018
Official wording
Reason: Decreasing performance overtime.
Code information: Lot # RS 3092, SS 1737
Distribution pattern: Minnesota and Texas Foreign: Iran
Derived failure modes
-
Unknown
Decreasing performance overtime.