Z-1014-2012

West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the qualitative...

Name: Z-1014-2012 West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the qualitative...
Creator: Inverness Medical
Published: 2008-10-08
License: https://open.fda.gov/license/

Inverness Medical, Inc. / initiated 2008-10-08 / Terminated / root cause: manufacturing process

FDA source

Inverness Medical began a recall of 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... on 2008-10-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1014-2012
Status: Terminated
Initiated: 2008-10-08
Posted: 2012-02-14
Terminated: 2012-02-15
Recalling firm: Inverness Medical, Inc.
Product: 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.
Product code: NOP Elisa, Antibody, West Nile Virus
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
Root cause tag: manufacturing process
FDA 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 recall call 609-627-8038.
Quantity in commerce: 289 Kits
Distribution: Worldwide Distribution including ND, PA, TX, MN; and the country of Canada
Product codes and lots: Lot 07262 (Canada), and Lot 08118 (Four customers in USA)

Product code NOP

K041231Class IIWest Nile Virus Igm Capture Elisa, Model E-Wnv02mPanbio Limited / cleared 2004-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)