Focus Diagnostics Recalls West Nile Virus IgG Test Kits
Focus Diagnostics is recalling specific lots of West Nile Virus IgG test kits due to a higher false positive rate.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a diagnostic error (false positives) rather than a direct physical injury or contamination.
Plain-English summary
Focus Diagnostics Inc is recalling 425 units of the West Nile Virus IgG DxSelect kit (Catalog No. EL0300G). The recall affects kit lots 122150, 122155, 122641, 122650, and 122859, which include West Nile Virus IgG Antigen Wells (Catalog Number EL0351, Lot Number 121117). The product is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum.
The firm initiated the recall because the affected lots showed higher reactivity with some samples, which may reflect a higher false positive rate. This issue could lead to incorrect presumptive laboratory diagnoses of West Nile virus infection.
The affected products were distributed worldwide, including the United States (nationwide), Canada, Deuche, France, Greece, Mexico, Israel, and Japan. Users should stop using the affected kits and contact Focus Diagnostics for instructions on returning or replacing the product.
The recalled product
- 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…
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 425
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
Distributed nationwide across the United States.
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