LumiQuick Methylphenidate Test Card Recalled for Unapproved Distribution
LumiQuick Diagnostics is recalling Methylphenidate Test Cards because they were shipped to locations without required FDA regulatory 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. The hazard is a regulatory compliance issue (unapproved distribution) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
LumiQuick Diagnostics Inc. is recalling Methylphenidate Test Cards (Catalog number 74056, all lots) due to regulatory compliance issues. The recall involves all units of the product.
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 indicates the devices were distributed without the necessary regulatory authorization for those specific sites.
The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. Consumers and healthcare providers should stop using the recalled test cards and contact the manufacturer for further instructions.
The recalled product
- Product
- Methylphenidate Test Card; 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: 74056
- 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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