LumiQuick K2 Test Strips Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling K2 Test Strips because they were shipped to locations without 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 does not report any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the K2 (synthetic Marijuana) Test Strip, catalog number 74065. The recall involves products distributed in California, Florida, New Jersey, Texas, and New York.
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. This indicates the devices were distributed without the necessary regulatory authorization for those specific sites.
Consumers who purchased these test strips should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Hazard
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: 74065
- 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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