Z-1147-03

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma...

Name: Z-1147-03 Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma...
Creator: Zeus Scientific Inc
Published: 2001-06-22
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2001-06-22 / Terminated / root cause: sterility

FDA source

Zeus Scientific Inc began a recall of Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO on 2001-06-22. The reason FDA records is "Bacterial contamination of the high positive control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1147-03
Status: Terminated
Initiated: 2001-06-22
Posted: 2003-08-21
Terminated: 2003-08-20
Recalling firm: Zeus Scientific LLC
Product: Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: Bacterial contamination of the high positive control.
Root cause tag: sterility
FDA root cause: Other
Action: Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.
Quantity in commerce: 130
Distribution: All product was shipped to St. Louis, MO
Product codes and lots: Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001

Product code MID

K984173Class IIThe Aptus (Automated) Application of the Anti-Cardiolipin Iga Elisa Test SystemZeus Scientific, Inc. / cleared 1998-12-22

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)