LumiQuick Morphine Strip Recalled for Unapproved Distribution in US
LumiQuick Diagnostics is recalling Morphine Strip (300) products distributed in California, Florida, New Jersey, Texas, and New York because they were shipped to locations without approved applications for PMA, IDE, or 510(k) 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, but the source text does not report any illnesses, injuries, or deaths. The hazard is a regulatory compliance issue regarding distribution to unapproved locations, which fits the criteria for a moderate severity recall involving low-risk or theoretical harm without reported adverse events.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Morphine Strip (300) (Catalog number: 74029). The recall involves products distributed in the states of California, Florida, New Jersey, Texas, and New York.
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. This regulatory issue means the devices were distributed in a manner that does not comply with FDA requirements for marketing medical devices.
Consumers and healthcare facilities in the affected states should stop using the recalled Morphine Strip (300) products and contact LumiQuick Diagnostics Inc. for further instructions on how to return or dispose of the items.
The recalled product
- Product
- Morphine Strip (300); 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: 74029
- 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
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