LumiQuick Benzodiazepine Test Card Recalled for Unauthorized Distribution
LumiQuick Diagnostics Inc. is recalling Benzodiazepine Test Cards because they were shipped to US locations without approved FDA applications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 labeling issue rather than a direct safety threat.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Benzodiazepine Test Cards, catalog number 74018, all lots. The recall involves all units of this product.
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.
Consumers who have this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- Benzodiazepine 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: 74018
- 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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