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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
3160240B/1
Products Sold
3160240B/1
Diasorin Inc. is recalling DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or s due to A lot to lot inconsistency was noted on kits of ETI EBNA G.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A lot to lot inconsistency was noted on kits of ETI EBNA G.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026