Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.
FDA device recall Z-1970-2010 · posted 2010-07-08 · Terminated
Recall details
- Recalling firm
- Biokit U.S.A. Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LGC
- Quantity affected
- 192 kits
- Distribution
- US (CA, FL, GA, IN, KY, MA, NY, VA) and UK
- Date initiated
- 2010-04-14
- Date posted
- 2010-07-08
- Date terminated
- 2012-01-26
- Location
- Bedford, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POCKIT HSV 2 RAPID TEST (K983886) | Diagnology , Ltd. | 1999-08-19 |