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U.S. Department of Health and Human Services

Class 2 Device Recall West Nile Virus IgM Capture ELISA

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  Class 2 Device Recall West Nile Virus IgM Capture ELISA see related information
Date Initiated by Firm October 08, 2008
Date Posted February 14, 2012
Recall Status1 Terminated 3 on February 15, 2012
Recall Number Z-1014-2012
Recall Event ID 50701
510(K)Number K041231  
Product Classification Elisa, antibody, West Nile Virus - Product Code NOP
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.
Code Information Lot 07262 (Canada), and Lot 08118 (Four customers in USA)
Recalling Firm/
Manufacturer		 Inverness Medical
532 Seventeen Mile Rocks Rd
Sinnamon Park Australia
For Additional Information Contact
609-627-8038
Manufacturer 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
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NOP and Original Applicant = PANBIO LIMITED
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