DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C
FDA device recall Z-0658-05 · posted 2005-03-29 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.
- Action taken
- Customers were notified of the product and problem via telephone and instructed to check any remaining inventory and discard all incorrect plates. Replacement plates were offered.
- Root cause
- Other
- Status
- Terminated
- Product code
- LSE
- Quantity affected
- 46
- Distribution
- FL, TX & UT
- Date initiated
- 2004-11-01
- Date posted
- 2005-03-29
- Date terminated
- 2006-07-22
- 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 |
|---|---|---|
| ETI-EA-G ASSAY (K992191) | DiaSorin, Inc. | 1999-07-12 |