LumiQuick Cocaine Test Card Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling Cocaine Test Cards 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (unauthorized distribution) rather than a direct physical safety defect with reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Cocaine Test Card (Catalog number 74020). 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.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these devices.
Consumers and distributors should stop using the affected Cocaine Test Cards and contact the recalling firm for further instructions.
The recalled product
- Product
- Cocaine 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: 74020
- 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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