LumiQuick Dengue Test Cards Recalled for Lack of FDA Clearance
LumiQuick Diagnostics is recalling all lots of its Dengue NS1 Ag/IgG/M Ab Duo Test Cards because they were shipped to US locations without the required FDA clearance.
What this means for you
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 II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Dengue NS1 Ag/IgG/M Ab Duo Test Card (Catalog number 71087). The recall is being conducted because the products were shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. The recall covers all lots of the product.
Consumers and healthcare providers who have purchased or received these test cards should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
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 (2)
- Catalog number: 71087
- All lots
Distribution
Part of a larger recall action
This product is one of 80 recalled by LumiQuick Diagnostics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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