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U.S. Department of Health and Human Services

Class 2 Device Recall Biokit and SureVue HSV2 Rapid Test

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  Class 2 Device Recall Biokit and SureVue HSV2 Rapid Test see related information
Date Initiated by Firm April 14, 2010
Date Posted July 08, 2010
Recall Status1 Terminated 3 on January 26, 2012
Recall Number Z-1971-2010
Recall Event ID 55316
510(K)Number K983886  
Product Classification Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
Product Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395.
20 test Kit
In Vitro Diagnostic test for Herpes Simplex Virus 2
Code Information Batch M691 (expiry: 2010/09) Batch M699 (expiry 2010/12)
Recalling Firm/
Manufacturer		 Biokit U.S.A. Inc.
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact Rita Grueter
800-926-3353
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 8 kits
Distribution US (CA, FL, GA, IN, KY, MA, NY, VA) and UK
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LGC and Original Applicant = DIAGNOLOGY LTD.
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