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U.S. Department of Health and Human Services

Class 2 Device Recall HerpeSelect 1 and 2 Immunoblot IgG Kit

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 Class 2 Device Recall HerpeSelect 1 and 2 Immunoblot IgG Kitsee related information
Date Initiated by FirmJuly 06, 2007
Date PostedAugust 17, 2008
Recall Status1 Terminated 3 on June 25, 2009
Recall NumberZ-1764-2008
Recall Event ID 47459
510(K)NumberK000238 
Product Classification Enzyme Linked Immunoabsorbent Assay - Product Code LGC
ProductHerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.
Code Information Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)
Recalling Firm/
Manufacturer		 Focus Diagnostics Inc
10703 Progress Way
Cypress CA 90630-4714
For Additional Information Contact
714-220-1900
Manufacturer Reason
for Recall		A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
FDA Determined
Cause 2		Process design
ActionFocus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.
Quantity in CommerceLot Code 063169 - 97 Kits, Lot Code 063354 - 16 Kits, Lot Code 063355 - 74 Kits
DistributionWorldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.
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 = LGC
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