LumiQuick THC Strip Recalled for Unauthorized Distribution in US
LumiQuick Diagnostics Inc. is recalling all lots of THC Strip (Catalog 74035) 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, which typically corresponds to a moderate severity score when no specific physical injury or illness is reported, but the product lacks required regulatory clearance.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the THC Strip, catalog number 74035. 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 lots of the product.
Consumers who possess these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- THC Strip; 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 (1)
- Catalog number: 74035 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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