Recall Z-1014-2012 ยท NOP Elisa, Antibody, West Nile Virus
Inverness Medical
West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis/meningitis. Positive results must be confirmed by plaque reduction neutralization test (P
| Date | Feb 14, 2012 (initiated Oct 8, 2008) |
| Status | Terminated |
| Reason | It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. Internal quality assurance testing has shown that the products are performing within the release specifications, although there has been a slight shift in the cut-off which may lead to an increase in the number of positive results obta |
| Root cause | Nonconforming Material/Component |
| Action | Inverness Medical sent an Urgent In Vitro Diagnostic Recall letter dated October 6, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use, destroy any unused or partially used test kits of the affected lot(s), and complete the table and certification of compliance. Customers were asked to fax back the completed form to inverness Medical at 1-609-527-8054. Replacement stock would be forwarded to them at no cost when the new lot becomes available. For questions regarding this r |
| Quantity | 289 Kits |
| Distribution | Worldwide Distribution including ND, PA, TX, MN; and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M Panbio Limited, Aug 10, 2004 |