Z-0755-2007

DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or...

Name: Z-0755-2007 DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or...
Creator: Diasorin Inc.
Published: 2007-03-14
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2007-03-14 / Terminated

FDA source

Diasorin Inc. began a recall of 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... on 2007-03-14. The reason FDA records is "A lot to lot inconsistency was noted on kits of ETI EBNA G". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0755-2007
Status: Terminated
Initiated: 2007-03-14
Posted: 2007-04-24
Terminated: 2007-07-15
Recalling firm: Diasorin Inc.
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
Product code: LLM Test, Antigen, Nuclear, Epstein-Barr Virus
Reason for recall: A lot to lot inconsistency was noted on kits of ETI EBNA G.
FDA 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 in commerce: 203
Distribution: Nationwide and Canada.
Product codes and lots: 3160240B/1

Product code LLM

K946158Class IIncstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitIncstar Corp. / cleared 1995-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)