DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detect
FDA device recall Z-0755-2007 · posted 2007-04-24 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- A lot to lot inconsistency was noted on kits of ETI EBNA G.
- Action taken
- All consignees will be notified by phone followed by a notification letter sent by fax March 14, 2007. The distributors are instructed to forward the notification to the customers who have received the affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLM
- Quantity affected
- 203
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-03-14
- Date posted
- 2007-04-24
- Date terminated
- 2007-07-15
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (K946158) | Incstar Corp. | 1995-06-09 |