LumiQuick Methadone Test Cards Recalled for Lack of FDA Clearance
LumiQuick Diagnostics is recalling Methadone Test Cards because they were shipped to locations without approved FDA applications or 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, indicating a regulatory or compliance issue rather than a direct safety threat.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Methadone Test Card (Catalog number 74026). 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 and healthcare providers should stop using the affected Methadone Test Cards and contact the manufacturer for further instructions.
The recalled product
- Product
- Methadone Test Card; 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: 74026
- 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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