Z-0961-03

Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the...

Name: Z-0961-03 Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the...
Creator: Zeus Scientific Inc
Published: 2001-03-19
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2001-03-19 / Terminated

FDA source

Zeus Scientific Inc began a recall of Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles... on 2001-03-19. The reason FDA records is "Mix-up between low positive and negative controls". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0961-03
Status: Terminated
Initiated: 2001-03-19
Posted: 2003-07-02
Terminated: 2006-10-03
Recalling firm: Zeus Scientific LLC
Product: Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
Product code: LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Reason for recall: Mix-up between low positive and negative controls.
FDA root cause: Other
Action: Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus.
Quantity in commerce: 15 kits
Distribution: NJ
Product codes and lots: Lot No: 00008066; Expiration Date: 08-11-2001.

Product code LJB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)