Z-0927-05

DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern...

Name: Z-0927-05 DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern...
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 Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United... on 2004-11-01. The reason FDA records is "DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0927-05
Status: Terminated
Initiated: 2004-11-01
Posted: 2005-06-25
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).
FDA root cause: Other
Action: Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered.
Quantity in commerce: 49
Distribution: NY, KS, GA & MT
Product codes and lots: Catalog no. 7800, lots FS1123 and FS2184

Product code MID

K001981Class IIDiastat Anti-Cardiolipin Iga, Model Fcar 500Axis-Shield , Ltd. / cleared 2000-08-21

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)