Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test for Herpes Simplex Virus 2
FDA Recall Z-1971-2010 · Posted 2010-07-08
Recalling FirmBiokit U.S.A. Inc.
Recall StatusTerminated
Product CodeLGC
Date Initiated2010-04-14
Date Terminated2012-01-26
Product Quantity8 kits
Reason for Recall
Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.
Firm Action
Biokit USA notified US Customers by fax on 2/18/10 of the reason for the kit recall and requested to discard any remaining units. Accounts were advised to retest patients or review test results. Questions are directed to the firm at 800-926-3353.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US (CA, FL, GA, IN, KY, MA, NY, VA) and UK
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.