Z-1065-03

Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative...

Name: Z-1065-03 Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative...
Creator: Zeus Scientific Inc
Published: 2000-02-24
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2000-02-24 / Terminated

FDA source

Zeus Scientific Inc began a recall of Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human... on 2000-02-24. The reason FDA records is "The high positive control/low positive standard ratio recovering too low". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1065-03
Status: Terminated
Initiated: 2000-02-24
Posted: 2003-07-30
Terminated: 2004-10-25
Recalling firm: Zeus Scientific LLC
Product: Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
Product code: LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Reason for recall: The high positive control/low positive standard ratio recovering too low.
FDA root cause: Other
Action: Recall letters sent out via DHL on 2/24/2000
Quantity in commerce: 205
Distribution: The two lots were shipped to St. Louis, MO. No subrecall was initiated.
Product codes and lots: Product Number: 514-B (Sigma Diagnostics) Lot Numbers: 020K6491 Exp. 10-02-2001; 090K6483 Exp. 5-31-2002.

Product code LFX

K984180Class IIThe Aptus (Automated) Application of the Rubella Igm Elisa Test SystemZeus Scientific, Inc. / cleared 1999-07-20

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)