LumiQuick Salmonella typhi Antigen Test Card Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling Salmonella typhi Antigen Test Cards 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, but the source text indicates a regulatory compliance issue (shipping without clearance) rather than a specific product defect causing harm. No injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary or regulatory recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Salmonella typhi Antigen Test Card (Catalog number 71028). The recall was initiated 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 recalling firm for further instructions.
The recalled product
- Product
- Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
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: 71028
- 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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