LumiQuick Drugs of Abuse Panel Test Device Recalled for Regulatory Violations
LumiQuick Diagnostics Inc. is recalling its Drugs of Abuse Panel Test Device because it was shipped to locations without required FDA approvals.
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 specific health hazards, indicating a regulatory compliance issue rather than a direct safety threat.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling its Drugs of Abuse Panel Test Device, catalog number 74007, all lots. 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 recall covers all units of the specified catalog number.
Consumers and healthcare providers who have purchased or received this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
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: 74007
- 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.
See all 80 products in this recall →Related recalls
Same manufacturer · LumiQuick Diagnostics Inc.
See all →- ModerateLumiQuick THC Test Cards Recalled for Unauthorized Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick Morphine Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick Dengue Test Cards Recalled for Lack of FDA Clearance
FDA (Devices) · 2014-04-16
- ModerateLumiQuick PSA Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateLumiQuick EDDP Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
Same hazard · regulatory violation
See all →- ModerateOne Step P in vitro diagnostic test lacks FDA premarket clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance
FDA (Devices) · 2026-05-13
- HighCucumber mint lemonade distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20
- HighGreen Reviver juice distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20