LumiQuick Cocaine Strip Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Cocaine Strips shipped to US 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. The hazard involves regulatory non-compliance (unapproved distribution) rather than a direct physical defect or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Cocaine Strip (Catalog number 74019). The recall involves products 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 is initiated because the products were shipped to locations lacking the necessary regulatory approvals.
Consumers and healthcare providers should stop using the affected Cocaine Strips and contact LumiQuick Diagnostics Inc. for further instructions.
The recalled product
- Product
- Cocaine 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 (2)
- Catalog number: 74019
- 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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