is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies
FDA device recall Z-2920-2018 · posted 2018-08-23 · Terminated
Recall details
- Recalling firm
- Euro Diagnostica AB
- Reason for recall
- Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- Action taken
- none
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 6
- Distribution
- MN
- Date initiated
- 2016-10-21
- 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 |
|---|---|---|
| DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 (K001574) | Axis-Shield | 2000-06-09 |