Z-1095-03

Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc...

Name: Z-1095-03 Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc...
Creator: Zeus Scientific Inc
Published: 2003-06-12
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2003-06-12 / Terminated / root cause: manufacturing process

FDA source

Zeus Scientific Inc began a recall of Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ on 2003-06-12. The reason FDA records is "The Calibrator included within the kit may be losing reactivity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1095-03
Status: Terminated
Initiated: 2003-06-12
Posted: 2003-08-12
Terminated: 2006-02-22
Recalling firm: Zeus Scientific LLC
Product: Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
Product code: LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Reason for recall: The Calibrator included within the kit may be losing reactivity.
Root cause tag: manufacturing process
FDA root cause: Other
Action: All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.
Quantity in commerce: 270 kits
Distribution: The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia.
Product codes and lots: Product Number 9Z9501G Lot Number: 03022371 exp. 2004-July; 03022392 exp. 2004-July; 03022472 exp 2004-July.

Product code LFZ

K891081Class IICmv Elisa Test SystemZeus Scientific, Inc. / cleared 1989-06-02

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)