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U.S. Department of Health and Human Services

Class 3 Device Recall West Nile Virus IgG DxSelect

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 Class 3 Recall
West Nile Virus IgG DxSelect
see related information
Date Posted October 31, 2012
Recall Status1 Terminated on December 04, 2012
Recall Number Z-0182-2013
Recall Event ID 63387
Premarket Notification
510(K) Number
K031953 
Product Classification Elisa, Antibody, West Nile Virus - Product Code NOP
Product 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 West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
Code Information 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.
Recalling Firm/
Manufacturer
Focus Diagnostics Inc
11331 Valley View St
Cypress, California 90630-5366
Manufacturer Reason
for Recall
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 425 units
Distribution Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NOP and Original Applicant = FOCUS TECHNOLOGIES, INC.
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