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Terminated

Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.

FDA Recall Z-1970-2010 · Posted 2010-07-08

Recalling FirmBiokit U.S.A. Inc.
Recall StatusTerminated
Product CodeLGC
Date Initiated2010-04-14
Date Terminated2012-01-26
Product Quantity192 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.

K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd. · 1999-08-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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