is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum
FDA device recall Z-2922-2018 · 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
- LKJ
- Quantity affected
- 4
- 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 |
|---|---|---|
| DISTAT ANTI-SCL-70 KIT (K912291) | Shield Diagnostics, Ltd. | 1991-07-30 |