Focus Diagnostics Inc HerpeSelect 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HerpeSelect 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.
Brand
Focus Diagnostics Inc
Lot Codes / Batch Numbers
Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)
Products Sold
Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)
Focus Diagnostics Inc is recalling HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence o due to A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Red. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Focus 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, IL, NY, OH
Page updated: Jan 10, 2026