LumiQuick Methylphenidate Test Strips Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Methylphenidate Test Strips because they were shipped to locations without required FDA clearances.
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 corresponds to a moderate severity score when no specific physical injuries or illnesses are reported in the source text.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling all lots of Methylphenidate Test Strips, catalog number 74055. 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 test strips and contact the manufacturer for further instructions.
The recalled product
- Product
- Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054
- Manufacturer
- LumiQuick Diagnostics Inc.
- 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: 74055
- 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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