LumiQuick Amphetamine Test Cards Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling Amphetamine Test Cards because they were shipped to locations without required FDA clearances.
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 corresponds to a moderate severity score when no specific physical injury or illness is reported, but rather a regulatory or labeling issue.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Amphetamine Test Cards (Catalog number 74014, all lots) because the products were shipped to US locations that do not have approved applications for PMA, IDE, or 510(k) clearance. The recall covers all lots of the product.
The products were distributed in the states of California, Florida, New Jersey, Texas, and New York. The recall is due to regulatory non-compliance regarding the distribution of medical devices to unapproved facilities.
Consumers and facilities should stop using the affected test cards and contact the recalling firm for further instructions.
The recalled product
- Product
- Amphetamine 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: 74014
- 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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