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
FDA Recall Z-0755-2007 · Posted 2007-04-24
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Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeLLM
Date Initiated2007-03-14
Date Terminated2007-07-15
Product Quantity203
Reason for Recall
A lot to lot inconsistency was noted on kits of ETI EBNA G.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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