LumiQuick Malaria Pan Antigen Test Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling Malaria pan Antigen Tests because they were shipped to US locations without approved PMA, IDE, or 510(k) 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a regulatory violation regarding clearance, rather than a direct physical defect causing injury.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Malaria pan Antigen Test, catalog number 71053. 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. No specific lot numbers are excluded, as the recall covers all lots of the specified catalog number.
Consumers and healthcare facilities should stop using the affected Malaria pan Antigen Tests and contact LumiQuick Diagnostics Inc. for further instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Malaria pan Antigen 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: 71053
- 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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