LumiQuick Fentanyl Test Card Recalled for Unauthorized Distribution
LumiQuick Diagnostics Inc. is recalling Fentanyl 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. The hazard involves regulatory non-compliance (unauthorized distribution) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Fentanyl Test Cards (Catalog number 74058, all lots) manufactured in Santa Clara, CA. 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. This indicates the devices were distributed without the necessary regulatory authorization for their specific use or location.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. Consumers who possess these test cards should stop using them and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Fentanyl 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: 74058
- 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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