LumiQuick Propoxyphene Test Strips Recalled for Unapproved Distribution
LumiQuick Diagnostics Inc. is recalling Propoxyphene Test Strips because they were shipped to US 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is regulatory non-compliance regarding distribution to unapproved locations, rather than a direct physical defect or reported injury.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of the Propoxyphene Test Strip (Catalog number 74051). The recall is being conducted 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 who have purchased or received these test strips should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Propoxyphene 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: 74051
- 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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