LumiQuick Oxycodone Test Card Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Oxycodone Test Cards because they were shipped to US locations without required FDA approvals.
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 health consequences. The source text does not report any specific injuries or illnesses, and the hazard is related to regulatory compliance rather than a direct physical defect.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Oxycodone Test Card (Catalog number 74044). 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 providers should stop using the affected test cards and contact the manufacturer for further instructions.
The recalled product
- Product
- Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
- 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: 74044
- 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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