Recall Z-0182-2013 ยท NOP Elisa, Antibody, West Nile Virus
Focus Diagnostics Inc
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics Wes
| Date | Oct 31, 2012 (initiated Oct 3, 2012) |
| Status | Terminated |
| Reason | The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate. |
| Root cause | Nonconforming Material/Component |
| Action | Focus Diagnostics Inc., sent a Urgent Medical Device Recall letter dated October 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received at least one of the effected lots in the month of August 2012. Please document the number of kits in your inventory on the table below, even if zero (0), and fax to 562-240-6526. For further questions please call (714) 220-1900. |
| Quantity | 425 units |
| Distribution | Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G Focus Technologies, Inc., Oct 22, 2003 |