Z-0632-05

DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific...

Name: Z-0632-05 DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific...
Creator: Diasorin Inc.
Published: 2004-01-23
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-01-23 / Terminated

FDA source

Diasorin Inc. began a recall of DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800... on 2004-01-23. The reason FDA records is "DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0632-05
Status: Terminated
Initiated: 2004-01-23
Posted: 2005-03-18
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
FDA root cause: Other
Action: Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.
Quantity in commerce: 16 kits
Distribution: GA, NY & KS
Product codes and lots: catalog # 7800, lot # 039229, expiration date 12/23/04

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)