FDA Medical Device Recalls (openFDA)
Biokit U.S.A. Inc.: Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test for Herpes Simplex Virus 2
- Recall number
- Z-1971-2010
- Recalling firm
- Biokit U.S.A. Inc.
- Product
- Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test for Herpes Simplex Virus 2
- Status
- Terminated
- Initiated
- 2010-04-14
- Posted
- 2010-07-08
- Terminated
- 2012-01-26
- Reason
- 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
- 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
- 8 kits
- Distribution
- US (CA, FL, GA, IN, KY, MA, NY, VA) and UK
- Lot, serial or model codes
- Batch M691 (expiry: 2010/09) Batch M699 (expiry 2010/12)
- 510(k) numbers
- ["K983886"]
- PMA numbers
- not on file
- Product code
- LGC
- Firm FEI
- 1000513333
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28