LumiQuick Salmonella Typhi Test Recalled for Lack of FDA Clearance
LumiQuick Diagnostics is recalling Salmonella typhi IgG/IgM Duo Tests because they were shipped to US locations without 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, but the source text indicates a regulatory compliance issue (lack of clearance) rather than a specific physical defect or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling the Salmonella typhi IgG/IgM Duo Test, catalog number 71055, all lots. The recall was initiated because the products were shipped to US locations that do not have approved applications for Premarket Approval (PMA), Investigational Device Exemption (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 units of this specific catalog number.
Consumers and healthcare providers who have purchased or received these tests should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Salmonella typhi IgG/IgM Duo Test; 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: 71055
- 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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