LumiQuick Oxycodone Strip Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Oxycodone Strips because they were shipped to US locations without required FDA clearance.
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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is primarily regulatory (unapproved distribution) rather than a direct physical defect.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Oxycodone Strip (Catalog number 74043). The recall was initiated because the products were shipped to US locations that do not have approved applications for Premarket Approval (PMA), Investigational Device Exemption (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 lots of the product.
Consumers and healthcare providers should stop using the affected Oxycodone Strips and contact the recalling firm for further instructions.
The recalled product
- Product
- Oxycodone Strip; 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: 74043
- 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 · unapproved distribution
See all →- ModerateOne Step P in vitro diagnostic test lacks FDA premarket clearance
FDA (Devices) · 2026-05-13
- ModerateReusable hip trial components recalled over missing FDA premarket authorization
FDA (Devices) · 2026-01-28
- ModerateBaxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution
FDA (Devices) · 2024-05-01
- ModerateVyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval
FDA (Devices) · 2023-12-13
- HighDual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance
FDA (Devices) · 2023-01-04