Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determin
FDA device recall Z-2918-2018 · posted 2018-08-23 · Terminated
Recall details
- Recalling firm
- Euro Diagnostica AB
- Reason for recall
- Decreasing performance overtime.
- Action taken
- None
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NHX
- Quantity affected
- 25 kits (US only)
- Distribution
- Minnesota and Texas Foreign: Iran
- Date initiated
- 2016-02-14
- Date posted
- 2018-08-23
- Date terminated
- 2019-11-05
- Location
- Malmo, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMUNOSCAN CCPLUS (K091657) | Euro-Diagnostica AB | 2009-11-19 |