Z-1970-2010

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

Name: Z-1970-2010 Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes...
Creator: Biokit U.S.A. Inc.
Published: 2010-04-14
License: https://open.fda.gov/license/

Biokit USA, Inc. / initiated 2010-04-14 / Terminated / root cause: manufacturing process

FDA source

Biokit U.S.A. Inc. began a recall of Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2 on 2010-04-14. The reason FDA records is "Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1970-2010
Status: Terminated
Initiated: 2010-04-14
Posted: 2010-07-08
Terminated: 2012-01-26
Recalling firm: Biokit USA, Inc.
Product: Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.
Product code: LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
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.
Root cause tag: manufacturing process
FDA root cause: 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: 192 kits
Distribution: US (CA, FL, GA, IN, KY, MA, NY, VA) and UK
Product codes and lots: Batch M691 (expiry: 2010/09) Batch M699 (expiry 2010/12)

Product code LGC

K983886Class IIPockit Hsv 2 Rapid TestDiagnology , Ltd. / cleared 1999-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)