LumiQuick H. Pylori Test Cards Recalled for Regulatory Non-Compliance
LumiQuick Diagnostics is recalling H. Pylori Ab Test Cards because they were shipped to locations without approved FDA applications.
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 adverse health consequences. The specific issue is regulatory non-compliance regarding distribution to unapproved locations, rather than a direct product defect causing injury.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the H. Pylori Ab Test Card-Serum (Catalog number 71046). 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 facilities should stop using the affected test cards and contact LumiQuick Diagnostics Inc. for further instructions on returns or replacements.
The recalled product
- Product
- H. Pylori Ab Test Card-Serum; 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: 71046
- 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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