Recall Z-0658-05 ยท LSE Epstein-Barr Virus, Other
Diasorin Inc.
DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C
| Date | Mar 29, 2005 (initiated Nov 1, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 46 |
| Distribution | FL, TX & UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992191 | ETI-EA-G ASSAY DiaSorin, Inc., Jul 12, 1999 |