Z-0572-05

Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum...

Name: Z-0572-05 Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum...
Creator: Diasorin Inc.
Published: 2003-09-10
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2003-09-10 / Terminated

FDA source

Diasorin Inc. began a recall of Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota... on 2003-09-10. The reason FDA records is "Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0572-05
Status: Terminated
Initiated: 2003-09-10
Posted: 2005-03-08
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285
Product code: LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Reason for recall: Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.
FDA root cause: Other
Action: Kit was initially placed on hold. Later Kit was discontinued and an alternate which would run correctly on the ETI-Max 3000 automated platform was found and offered to customers.
Quantity in commerce: 99 kits
Distribution: AL, CA, IL, KS, MA, MI & NJ
Product codes and lots: Manufacturer part #4620, lot # 111261.

Product code LFY

K900688Class IIVaricella Zoster Igg Clin-Elisa Test KitClinical Sciences, Inc. / cleared 1990-05-15

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)