Recall Z-1970-2010 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Biokit U.S.A. Inc.
Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.
| Date | Jul 8, 2010 (initiated Apr 14, 2010) |
| Status | Terminated |
| 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 | 192 kits |
| Distribution | US (CA, FL, GA, IN, KY, MA, NY, VA) and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983886 | POCKIT HSV 2 RAPID TEST Diagnology , Ltd., Aug 19, 1999 |