Z-0658-05

DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

Name: Z-0658-05 DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C
Creator: Diasorin Inc.
Published: 2004-11-01
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-11-01 / Terminated

FDA source

Diasorin Inc. began a recall of DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C on 2004-11-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0658-05
Status: Terminated
Initiated: 2004-11-01
Posted: 2005-03-29
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C
Product code: LSE Epstein-Barr Virus, Other
Reason for recall: 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.
FDA 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 in commerce: 46
Distribution: FL, TX & UT
Product codes and lots: catalog no. 7570, Lot # 113963C

Product code LSE

K992191Class IEti-Ea-G AssayDiaSorin, Inc. / cleared 1999-07-12

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)