RecallDepth

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

Company
Diasorin Inc.
Recall Initiated
September 10, 2003
Posted
March 8, 2005
Terminated
July 22, 2006
Recall Number
Z-0572-05
Quantity
99 kits
Firm Location
Stillwater, MN

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.

Distribution

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

Lot / Code Info

Manufacturer part #4620, lot # 111261.

Root Cause

Other

Action Taken

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.

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