Z-0950-03

Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029

Name: Z-0950-03 Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029
Creator: Binding Site Inc The
Published: 2003-03-27
License: https://open.fda.gov/license/

The Binding Site / initiated 2003-03-27 / Terminated

FDA source

Binding Site Inc The began a recall of Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029 on 2003-03-27. The reason FDA records is "Risk of false positives". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0950-03
Status: Terminated
Initiated: 2003-03-27
Posted: 2003-06-21
Terminated: 2004-12-01
Recalling firm: The Binding Site
Product: Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: Risk of false positives.
FDA root cause: Other
Action: Recall notice was sent by fax March 27, 2003. The recall is complete.
Quantity in commerce: 239
Distribution: Nationwide.
Product codes and lots: Lot 074461

Product code MID

K983694Class IIAnticardiolipin Igm Screen Eia Diagnostic Test KitThe Binding Site, Ltd. / cleared 1999-02-05

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)