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Terminated

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

FDA Recall Z-0572-05 · Posted 2005-03-08

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeLFY
Date Initiated2003-09-10
Date Terminated2006-07-22
Product Quantity99 kits

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.

Firm 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.

Root Cause

Other

Distribution Pattern

AL, CA, IL, KS, MA, MI & NJ

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITClinical Sciences, Inc. · 1990-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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