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Terminated

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 (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics.

FDA Recall Z-1014-2012 · Posted 2012-02-14

Recalling FirmInverness Medical
Recall StatusTerminated
Product CodeNOP
Date Initiated2008-10-08
Date Terminated2012-02-15
Product Quantity289 Kits

Reason for Recall

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

Firm 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 recall call 609-627-8038.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution including ND, PA, TX, MN; and the country of Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041231WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02MPanbio Limited · 2004-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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