Z-0706-05

DiaSorin Analyte Specific Reagent

Name: Z-0706-05 DiaSorin Analyte Specific Reagent
Creator: Diasorin Inc.
Published: 2005-01-18
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2005-01-18 / Terminated / root cause: labeling and UDI

FDA source

Diasorin Inc. began a recall of DiaSorin Analyte Specific Reagent on 2005-01-18. The reason FDA records is "Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0706-05
Status: Terminated
Initiated: 2005-01-18
Posted: 2005-04-13
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: DiaSorin Analyte Specific Reagent
Product code: DGK Igg, Fitc, Antigen, Antiserum, Control
Reason for recall: Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers were notified of the incorrect expiration date and instructed to destroy the vials with the incorrect date and product replacement was offered.
Quantity in commerce: 1
Distribution: WA, MA, and Korea
Product codes and lots: lot # 926603-08

Product code DGK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)