LumiQuick Fentanyl Test Strips Recalled for Unauthorized Distribution
LumiQuick Diagnostics is recalling Fentanyl Test Strips because they were shipped to US locations without approved FDA applications.
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 level where the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Fentanyl Test Strips (Catalog number 74057, 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 units of this product.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. The recall is classified as Class II by the FDA.
Consumers who have purchased these test strips should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
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: 74057
- 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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