Recall Z-0755-2007 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus
Diasorin Inc.
DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285
| Date | Apr 24, 2007 (initiated Mar 14, 2007) |
| Status | Terminated |
| Reason | A lot to lot inconsistency was noted on kits of ETI EBNA G. |
| Root cause | Other |
| Action | 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. |
| Quantity | 203 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT Incstar Corp., Jun 9, 1995 |