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U.S. Department of Health and Human Services

Class 2 Device Recall DiaSorin Varicella Zoster ELISA Kit

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 Class 2 Device Recall DiaSorin Varicella Zoster ELISA Kitsee related information
Date Initiated by FirmSeptember 10, 2003
Date PostedMarch 08, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0572-05
Recall Event ID 30891
510(K)NumberK900688 
Product Classification Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster - Product Code LFY
ProductVarcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285
Code Information Manufacturer part #4620, lot # 111261.
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact
800-328-1482
Manufacturer 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 Determined
Cause 2		Other
ActionKit 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 Commerce99 kits
DistributionAL, CA, IL, KS, MA, MI & NJ
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LFY
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